Pub Date : 2016-07-01DOI: 10.4103/2468-5577.187081
J. Solanki, A. Thesia, Hitarth N. Mehta, C. Shah, Hemant Mehta
Most of studies on leprosy mainly focus on its somatic symptoms. There are few reports on evaluation of cardiac autonomic status by QTc interval. We performed a cross-sectional, case-control study to investigate the QTc (QT corrected for heart rate) interval difference between leprosy patients and healthy controls. Thirty leprosy patients and 30 age- and sex-matched healthy controls were included in this study. These leprosy patients, aged 41 years on average, suffered from leprosy for an average of 4 years. 55% of these patients had more than 10 skin patches, 66% of them had somatic neuropathy, and 33% of them had cardiac autonomic neuropathy. Electrocardiogram recording from lead II showed that QTc interval was significantly longer in patients with leprosy than in healthy controls (OR: 6, 95% CI: 1.17-30.72, P = 0.03). QTc interval was unrelated to age and duration of disease and it would not be influenced by the type of neuropathies and skin symptoms. QTc results revealed that patients with leprosy had a significantly higher risk for cardiac autonomic neuropathy than healthy controls.
对麻风病的研究大多集中在躯体症状上。用QTc间期评价心脏自主神经状态的报道很少。我们进行了一项横断面病例对照研究，以调查麻风病患者和健康对照者的QTc(校正心率的QT)间期差异。本研究包括30名麻风病患者和30名年龄和性别匹配的健康对照。这些麻风病患者平均年龄41岁，患麻风病的平均时间为4年。55%的患者有10个以上的皮肤斑块，66%的患者有躯体神经病变，33%的患者有心脏自主神经病变。II导联心电图记录显示，麻风病患者QTc间期明显长于健康对照组(OR: 6, 95% CI: 1.17-30.72, P = 0.03)。QTc间期与年龄、病程无关，不受神经病变类型和皮肤症状的影响。QTc结果显示，麻风病患者发生心脏自主神经病变的风险明显高于健康对照组。
{"title":"Evaluation of cardiac autonomic status using QTc interval in patients with leprosy","authors":"J. Solanki, A. Thesia, Hitarth N. Mehta, C. Shah, Hemant Mehta","doi":"10.4103/2468-5577.187081","DOIUrl":"https://doi.org/10.4103/2468-5577.187081","url":null,"abstract":"Most of studies on leprosy mainly focus on its somatic symptoms. There are few reports on evaluation of cardiac autonomic status by QTc interval. We performed a cross-sectional, case-control study to investigate the QTc (QT corrected for heart rate) interval difference between leprosy patients and healthy controls. Thirty leprosy patients and 30 age- and sex-matched healthy controls were included in this study. These leprosy patients, aged 41 years on average, suffered from leprosy for an average of 4 years. 55% of these patients had more than 10 skin patches, 66% of them had somatic neuropathy, and 33% of them had cardiac autonomic neuropathy. Electrocardiogram recording from lead II showed that QTc interval was significantly longer in patients with leprosy than in healthy controls (OR: 6, 95% CI: 1.17-30.72, P = 0.03). QTc interval was unrelated to age and duration of disease and it would not be influenced by the type of neuropathies and skin symptoms. QTc results revealed that patients with leprosy had a significantly higher risk for cardiac autonomic neuropathy than healthy controls.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82604165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-07-01DOI: 10.4103/2468-5577.187075
Liang Tian, Xiao-Zheng Du, Jin-hai Wang, Zhen-chang Zhang, Qi Yan, Lei Wang, Run-jie Sun, Bo Yuan, Xing-lan Li, Ting-zhuo Zhang
Background: Acupuncture can be used in clinical practice to promote motor recovery in patients with acute ischemic stroke and paralysis. It is an economical, safe, and effective method that can be easily implemented in clinical settings. However, although scalp acupuncture is an easy-to-perform micro-needle therapy, its efficacy in the treatment of hemiplegia resulting from acute ischemic stroke remains disputed. Methods/Design: This is a randomized parallel-controlled single-blind trial. It will be performed at the Department of Neurology, Second Hospital, Lanzhou University, China. Seventy-two patients suffering from acute ischemic stroke with paralysis will be randomly assigned to undergo 14 days of either conventional drug treatment (control group) or conventional drug treatment combined with scalp acupuncture that uses the twirling-needle method (once a day, 6 consecutive days followed by 1 day off per week). The primary outcome is the difference in National Institutes of Health Stroke Scale (NIHSS) scores between just after the stroke and 14 days after treatment. Secondary outcomes include motor recovery (assessed by the Fugl-Meyer Motor Scale) and activities of daily living (assessed by the Barthel index). Discussion: Objectively evaluating the efficacy of twirling-needle scalp acupuncture in the treatment of hemiplegia after acute ischemic stroke will provide evidence for assessing whether this method can improve motor recovery from hemiplegia resulting from acute ischemic stroke. Trial registration: This trial has been registered on 11 March 2016 in the Chinese Clinical Trial Registry (registration number: ChiCTR-IOR-16008083). Ethics: This trial has been approved by Ethics Committee, Second Hospital, Lanzhou University of China (approval number: 2016A-003) and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from the patients and their relatives.
{"title":"Scalp acupuncture twisting manipulation for treatment of hemiplegia after acute ischemic stroke in patients: study protocol for a randomized, parallel, controlled, single-blind trial","authors":"Liang Tian, Xiao-Zheng Du, Jin-hai Wang, Zhen-chang Zhang, Qi Yan, Lei Wang, Run-jie Sun, Bo Yuan, Xing-lan Li, Ting-zhuo Zhang","doi":"10.4103/2468-5577.187075","DOIUrl":"https://doi.org/10.4103/2468-5577.187075","url":null,"abstract":"Background: Acupuncture can be used in clinical practice to promote motor recovery in patients with acute ischemic stroke and paralysis. It is an economical, safe, and effective method that can be easily implemented in clinical settings. However, although scalp acupuncture is an easy-to-perform micro-needle therapy, its efficacy in the treatment of hemiplegia resulting from acute ischemic stroke remains disputed. Methods/Design: This is a randomized parallel-controlled single-blind trial. It will be performed at the Department of Neurology, Second Hospital, Lanzhou University, China. Seventy-two patients suffering from acute ischemic stroke with paralysis will be randomly assigned to undergo 14 days of either conventional drug treatment (control group) or conventional drug treatment combined with scalp acupuncture that uses the twirling-needle method (once a day, 6 consecutive days followed by 1 day off per week). The primary outcome is the difference in National Institutes of Health Stroke Scale (NIHSS) scores between just after the stroke and 14 days after treatment. Secondary outcomes include motor recovery (assessed by the Fugl-Meyer Motor Scale) and activities of daily living (assessed by the Barthel index). Discussion: Objectively evaluating the efficacy of twirling-needle scalp acupuncture in the treatment of hemiplegia after acute ischemic stroke will provide evidence for assessing whether this method can improve motor recovery from hemiplegia resulting from acute ischemic stroke. Trial registration: This trial has been registered on 11 March 2016 in the Chinese Clinical Trial Registry (registration number: ChiCTR-IOR-16008083). Ethics: This trial has been approved by Ethics Committee, Second Hospital, Lanzhou University of China (approval number: 2016A-003) and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from the patients and their relatives.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79575388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: In clinical practice, it is important to quickly and effectively treat manic episodes in patients with bipolar I disorder. Therefore, it is necessary to formulate an effective therapeutic protocol combining two or more drugs in order to rapidly alleviate symptoms within a short time frame (1 week). In this clinical trial protocol, the antipsychotics quetiapine, olanzapine and ziprasidone and the mood stabilizers valproate, oxcarbazepine and lithium will be used to treat manic episodes to investigate the efficacy and safety of these two types of drugs when used alone or in combination. Methods/Design: This trial will be performed at Guangzhou Brain Hospital, China. A total of 120 patients with bipolar I disorder, exhibiting manic or mixed episodes, will undergo two phases of medication. In the first phase, patients will be randomly assigned to receive oral valproate, oxcarbazepine, lithium, quetiapine, olanzapine or ziprasidone. In the second phase, combination drug treatment will be given, i.e., each patient will receive a combination of mood stabilizers and antipsychotics. Treatment will be given for a total of 6 weeks. Primary outcome measures will include changes in the Young Mania Rating Scale (YMRS) scores and dropout rates. Secondary outcome measures will include disease progression and the efficacy of treatment as evaluated with the Clinical Global Impression Scale, symptom severity as evaluated with the Global Assessment Scale, and anxiety and depression symptoms as evaluated with the Hamilton Anxiety Scale and the Hamilton Depression Scale, respectively. Discussion: This trial will provide preliminary evidence on the comparative efficacy and effectiveness of the commonly prescribed drugs, with attempts at optimizing pharmacological treatments of manic and mixed episodes. Trial registration: ClinicalTrials.gov identifier: NCT01893229; registered on 2 July 2013.
{"title":"Mood stabilizers and/or antipsychotic drugs for the treatment of manic episodes in bipolar I disorder: study protocol for a randomized controlled trial","authors":"Kangguang Lin, Ting Li, Kun Chen, Weicong Lu, Jiehua Kong, Gui-yun Xu","doi":"10.4103/2468-5577.181238","DOIUrl":"https://doi.org/10.4103/2468-5577.181238","url":null,"abstract":"Background: In clinical practice, it is important to quickly and effectively treat manic episodes in patients with bipolar I disorder. Therefore, it is necessary to formulate an effective therapeutic protocol combining two or more drugs in order to rapidly alleviate symptoms within a short time frame (1 week). In this clinical trial protocol, the antipsychotics quetiapine, olanzapine and ziprasidone and the mood stabilizers valproate, oxcarbazepine and lithium will be used to treat manic episodes to investigate the efficacy and safety of these two types of drugs when used alone or in combination. Methods/Design: This trial will be performed at Guangzhou Brain Hospital, China. A total of 120 patients with bipolar I disorder, exhibiting manic or mixed episodes, will undergo two phases of medication. In the first phase, patients will be randomly assigned to receive oral valproate, oxcarbazepine, lithium, quetiapine, olanzapine or ziprasidone. In the second phase, combination drug treatment will be given, i.e., each patient will receive a combination of mood stabilizers and antipsychotics. Treatment will be given for a total of 6 weeks. Primary outcome measures will include changes in the Young Mania Rating Scale (YMRS) scores and dropout rates. Secondary outcome measures will include disease progression and the efficacy of treatment as evaluated with the Clinical Global Impression Scale, symptom severity as evaluated with the Global Assessment Scale, and anxiety and depression symptoms as evaluated with the Hamilton Anxiety Scale and the Hamilton Depression Scale, respectively. Discussion: This trial will provide preliminary evidence on the comparative efficacy and effectiveness of the commonly prescribed drugs, with attempts at optimizing pharmacological treatments of manic and mixed episodes. Trial registration: ClinicalTrials.gov identifier: NCT01893229; registered on 2 July 2013.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87424818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-04-01DOI: 10.4103/2468-5577.181235
Maruli Simangunsong, Bihantoro, Zola Wijayanti, Echa Aisyah, Novarida Mustikawati, R. Tjandrawinata, Prihatini Hendri, N. Hidayah, Liana Susantos, Fenny, Deni Purnama
Background: In Indonesia, the incidence of stroke is growing rapidly every year and it becomes a burden to the government. Medications improving neurological function are required, in order to increase patient′s quality of life. There were an enzyme (lumbrokinase) secreted from the alimentary tract of earthworm and it has anti-thrombotic and thrombolytic effect so that it can be beneficial in the management and prevention of stroke. DLBS1033 is a standardized bioactive protein fraction derived from Lumbricus rubellus through a patented technology of extraction. DLBS1033 has been shown to have antithrombosis and thrombolytic activities. The safety profile of DLBS1033 was also demonstrated in toxicology studies, animal studies, and in healthy adult subjects. Based on its mechanism of action and safety profile, DLBS1033 can be considered beneficial on acute ischemic stroke patients. Through this clinical study, we will evaluate the efficacy and safety of the product in acute ischemic stroke management. Methods/Design: This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in the management of acute ischemic stroke. Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 (as DLBS1033 group). Functional outcomes will be measured using the Modified Rankin Scale (MRS) and The Modified National Institutes of Health Stroke (mNIHSS). Discussion: The study is expected to be a medical breakthrough in acute ischemic stroke management. Therefore, the morbidity and mortality of this disease can be lowered. Trial registration: ClinicalTrials.gov identifier: NCT02362984; registered on 3 February 2015.
{"title":"Role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study","authors":"Maruli Simangunsong, Bihantoro, Zola Wijayanti, Echa Aisyah, Novarida Mustikawati, R. Tjandrawinata, Prihatini Hendri, N. Hidayah, Liana Susantos, Fenny, Deni Purnama","doi":"10.4103/2468-5577.181235","DOIUrl":"https://doi.org/10.4103/2468-5577.181235","url":null,"abstract":"Background: In Indonesia, the incidence of stroke is growing rapidly every year and it becomes a burden to the government. Medications improving neurological function are required, in order to increase patient′s quality of life. There were an enzyme (lumbrokinase) secreted from the alimentary tract of earthworm and it has anti-thrombotic and thrombolytic effect so that it can be beneficial in the management and prevention of stroke. DLBS1033 is a standardized bioactive protein fraction derived from Lumbricus rubellus through a patented technology of extraction. DLBS1033 has been shown to have antithrombosis and thrombolytic activities. The safety profile of DLBS1033 was also demonstrated in toxicology studies, animal studies, and in healthy adult subjects. Based on its mechanism of action and safety profile, DLBS1033 can be considered beneficial on acute ischemic stroke patients. Through this clinical study, we will evaluate the efficacy and safety of the product in acute ischemic stroke management. Methods/Design: This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in the management of acute ischemic stroke. Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 (as DLBS1033 group). Functional outcomes will be measured using the Modified Rankin Scale (MRS) and The Modified National Institutes of Health Stroke (mNIHSS). Discussion: The study is expected to be a medical breakthrough in acute ischemic stroke management. Therefore, the morbidity and mortality of this disease can be lowered. Trial registration: ClinicalTrials.gov identifier: NCT02362984; registered on 3 February 2015.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82616206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-04-01DOI: 10.4103/2468-5577.181237
Li-li Wang, L. Du, L. Shan, Han-yu Dong, F. Jia
Background: Pointed foot deformity and mental retardation are common clinical manifestations in children with spastic cerebral palsy. Comprehensive rehabilitation training is performed in cerebral palsy children with mental retardation, but its clinical effect is not satisfactory. Acupuncture at acupoints related to the motor, sensory, foot-motor-sensory, language and equilibrium areas can promote intelligence and effectively relieve local muscle tension. We propose that acupuncture combined with rehabilitation training mitigates pointed foot deformities in children with spastic cerebral palsy and contributes to the development of intelligence. This prospective, randomized, controlled clinical study will test the above hypothesis. Functional magnetic resonance imaging will be utilized to observe the changes in acupuncture-activated brain regions and to elucidate the mechanisms of acupuncture in treatment of spastic cerebral palsy. Methods/Design: This is a prospective, randomized, controlled clinical trial. Sixty children with spastic cerebral palsy, hospitalized in the Out-Patient Clinic of the Department of Pediatric Neurological Rehabilitation, the First Hospital fo Jilin University of China, will be recruited for trial participation. All subjects will be equally and randomly divided into a treatment group and control group. Patients in the treatment group will be subjected to conventional rehabilitation training after acupuncture. Patients in the control group will receive conventional rehabilitation training alone. The treatment will last for 6 months. Primary outcomes will be Gross Motor Function Measure, ankle range of motion, Gesell Developmental Scale and surface electromyography. Secondary outcomes will be: modified Ashworth Scale of muscle spasticity, Fine Motor Function Measure, Gross Motor Function Classification System, and functional magnetic resonance imaging. Discussion: It is hoped that the experimental results can provide quantitative data for acupuncture combined with rehabilitation training in the treatment of spastic cerebral palsy. Trial registration: Chinese Clinical Trial Registry (registration No. ChiCTR-ONC-15007633) on December 24, 2015.
{"title":"Acupuncture combined with rehabilitation training improves pointed foot deformity and mental retardation in infants with spastic cerebral palsy: study protocol for a randomized controlled trial","authors":"Li-li Wang, L. Du, L. Shan, Han-yu Dong, F. Jia","doi":"10.4103/2468-5577.181237","DOIUrl":"https://doi.org/10.4103/2468-5577.181237","url":null,"abstract":"Background: Pointed foot deformity and mental retardation are common clinical manifestations in children with spastic cerebral palsy. Comprehensive rehabilitation training is performed in cerebral palsy children with mental retardation, but its clinical effect is not satisfactory. Acupuncture at acupoints related to the motor, sensory, foot-motor-sensory, language and equilibrium areas can promote intelligence and effectively relieve local muscle tension. We propose that acupuncture combined with rehabilitation training mitigates pointed foot deformities in children with spastic cerebral palsy and contributes to the development of intelligence. This prospective, randomized, controlled clinical study will test the above hypothesis. Functional magnetic resonance imaging will be utilized to observe the changes in acupuncture-activated brain regions and to elucidate the mechanisms of acupuncture in treatment of spastic cerebral palsy. Methods/Design: This is a prospective, randomized, controlled clinical trial. Sixty children with spastic cerebral palsy, hospitalized in the Out-Patient Clinic of the Department of Pediatric Neurological Rehabilitation, the First Hospital fo Jilin University of China, will be recruited for trial participation. All subjects will be equally and randomly divided into a treatment group and control group. Patients in the treatment group will be subjected to conventional rehabilitation training after acupuncture. Patients in the control group will receive conventional rehabilitation training alone. The treatment will last for 6 months. Primary outcomes will be Gross Motor Function Measure, ankle range of motion, Gesell Developmental Scale and surface electromyography. Secondary outcomes will be: modified Ashworth Scale of muscle spasticity, Fine Motor Function Measure, Gross Motor Function Classification System, and functional magnetic resonance imaging. Discussion: It is hoped that the experimental results can provide quantitative data for acupuncture combined with rehabilitation training in the treatment of spastic cerebral palsy. Trial registration: Chinese Clinical Trial Registry (registration No. ChiCTR-ONC-15007633) on December 24, 2015.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82520885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-04-01DOI: 10.6084/M9.FIGSHARE.3406555.V1
J. Huo, Bao-rui Liu, Yufei Yang, Jingqiu Hu
Background: Oxaliplatin, a platinum-based cytotoxic agent, is a widely used chemotherapeutic agent. Small-sample clinical trials and animal experiments have shown that Jiawei Huangqi Guizhi Wuwu Tang (a decoction of five components, including Radix Astragali and Ramulus Cinnamomi) effectively reduces peripheral neuropathy caused by oxaliplatin, but no confirmation exists from a prospective, multicenter, randomized, controlled, blinded clinical trial. Methods/Design: We plan to conduct such a trial that will be completed at the Department of Oncology, Jiangsu Provincial Hospital of Integrated Medicine, China, the Center of Oncology of Nanjing Drum Tower Hospital, China, and the Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, China. Sixty-four patients with colorectal cancer stages IIa-IV will be equally randomized into either the HD6610 granule group (oxaliplatin chemotherapy plus HD6610 granules, a granular form for Jiawei Huangqi Guizhi Wuwu Tang) or the HD6610 placebo group (oxaliplatin chemotherapy plus HD6610 placebo made of bitters, food coloring, and starch). Primary outcomes are the scores of the European Organization for Research and Treatment of Cancer′s Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy and the National Cancer Institute′s Common Terminology Criteria for Adverse Events Version 4.0. Secondary outcomes include the time of peripheral neuropathy occurrence, total neuropathy score, score of the European Organization for Research and Treatment of Cancer′s Core Quality of Life Questionnaire, and survival time. Other outcomes will be evaluated before treatment as well as 1 and 2 weeks and 2, 4, 8, 12, 16, 20, and 24 months after treatment. Discussion: This study will provide evidence that the clinical application of HD6610 can reduce oxaliplatin-induced peripheral neuropathy. Trial registration: ClinicalTrials.gov identifier: NCT02590367; registered on 14 September 2015. Ethical approval: The study protocol was approved by Jiangsu Provincial Hospital of Integrated Medicine in China (approval No. 2014ZX (KT)-010-02).
{"title":"HD6610 granules relieve oxaliplatin-induced peripheral neuropathy: study protocol for a multicenter randomized double-blind placebo-controlled trial","authors":"J. Huo, Bao-rui Liu, Yufei Yang, Jingqiu Hu","doi":"10.6084/M9.FIGSHARE.3406555.V1","DOIUrl":"https://doi.org/10.6084/M9.FIGSHARE.3406555.V1","url":null,"abstract":"Background: Oxaliplatin, a platinum-based cytotoxic agent, is a widely used chemotherapeutic agent. Small-sample clinical trials and animal experiments have shown that Jiawei Huangqi Guizhi Wuwu Tang (a decoction of five components, including Radix Astragali and Ramulus Cinnamomi) effectively reduces peripheral neuropathy caused by oxaliplatin, but no confirmation exists from a prospective, multicenter, randomized, controlled, blinded clinical trial. Methods/Design: We plan to conduct such a trial that will be completed at the Department of Oncology, Jiangsu Provincial Hospital of Integrated Medicine, China, the Center of Oncology of Nanjing Drum Tower Hospital, China, and the Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, China. Sixty-four patients with colorectal cancer stages IIa-IV will be equally randomized into either the HD6610 granule group (oxaliplatin chemotherapy plus HD6610 granules, a granular form for Jiawei Huangqi Guizhi Wuwu Tang) or the HD6610 placebo group (oxaliplatin chemotherapy plus HD6610 placebo made of bitters, food coloring, and starch). Primary outcomes are the scores of the European Organization for Research and Treatment of Cancer′s Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy and the National Cancer Institute′s Common Terminology Criteria for Adverse Events Version 4.0. Secondary outcomes include the time of peripheral neuropathy occurrence, total neuropathy score, score of the European Organization for Research and Treatment of Cancer′s Core Quality of Life Questionnaire, and survival time. Other outcomes will be evaluated before treatment as well as 1 and 2 weeks and 2, 4, 8, 12, 16, 20, and 24 months after treatment. Discussion: This study will provide evidence that the clinical application of HD6610 can reduce oxaliplatin-induced peripheral neuropathy. Trial registration: ClinicalTrials.gov identifier: NCT02590367; registered on 14 September 2015. Ethical approval: The study protocol was approved by Jiangsu Provincial Hospital of Integrated Medicine in China (approval No. 2014ZX (KT)-010-02).","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87578430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-04-01DOI: 10.4103/2468-5577.181234
Hao Wang, Y. Sun, Chenxi Wu, Zhaohui Zhu
Background: Arginylglycylaspartic acid (RGD) is a tripeptide composed of L-arginine, glycine, and L-aspartic acid that shows great affinity for the integrin αv β3 receptor. A RGD dimer labeled with 68Ga, 68Ga-BNOTA-PRGD2 was designed for positron-emission tomography/computed tomography (PET/CT) imaging post-stroke angiogenesis, which has rarely been used in the clinic. We aimed to perform a prospective open-label trial to validate the diagnostic value of 68 Ga-BNOTA-PRGD2 PET/CT in post-stroke angiogenesis. Methods/Design: A self-controlled open-label clinical trial will be performed at the PET Center, Department of Nuclear Medicine, Peking Union Medical College Hospital, China. Fifty patients with stroke will undergo 68 Ga-BNOTA-PRGD2 PET/CT, 18 F-FDG PET/CT, and magnetic resonance imaging (MRI) at 2 weeks, 3 months, and 1 year after stroke onset. Primary outcomes include the standardized uptake value (SUV) in the cerebral infarction area and the standardized uptake value ratio of the injured side to the contralateral side detected by 68 Ga-BNOTA-PRGD2 PET/CT. Secondary outcomes include the safety of brain 68 Ga-BNOTA-PRGD2 PET/CT used to evaluate post-stroke angiogenesis. Discussion: Findings from this trial will provide important reference evidence for use of 68 Ga-BNOTA-PRGD2 PET/CT to evaluate post-stroke angiogenesis. Trial registration: ClinicalTrials.gov identifier: NCT01656785; registered on 1 August 2012.
{"title":"68 Ga-BNOTA-PRGD2 PET/CT for evaluation of post-stroke angiogenesis: study protocol for a prospective open-label clinical trial","authors":"Hao Wang, Y. Sun, Chenxi Wu, Zhaohui Zhu","doi":"10.4103/2468-5577.181234","DOIUrl":"https://doi.org/10.4103/2468-5577.181234","url":null,"abstract":"Background: Arginylglycylaspartic acid (RGD) is a tripeptide composed of L-arginine, glycine, and L-aspartic acid that shows great affinity for the integrin αv β3 receptor. A RGD dimer labeled with 68Ga, 68Ga-BNOTA-PRGD2 was designed for positron-emission tomography/computed tomography (PET/CT) imaging post-stroke angiogenesis, which has rarely been used in the clinic. We aimed to perform a prospective open-label trial to validate the diagnostic value of 68 Ga-BNOTA-PRGD2 PET/CT in post-stroke angiogenesis. Methods/Design: A self-controlled open-label clinical trial will be performed at the PET Center, Department of Nuclear Medicine, Peking Union Medical College Hospital, China. Fifty patients with stroke will undergo 68 Ga-BNOTA-PRGD2 PET/CT, 18 F-FDG PET/CT, and magnetic resonance imaging (MRI) at 2 weeks, 3 months, and 1 year after stroke onset. Primary outcomes include the standardized uptake value (SUV) in the cerebral infarction area and the standardized uptake value ratio of the injured side to the contralateral side detected by 68 Ga-BNOTA-PRGD2 PET/CT. Secondary outcomes include the safety of brain 68 Ga-BNOTA-PRGD2 PET/CT used to evaluate post-stroke angiogenesis. Discussion: Findings from this trial will provide important reference evidence for use of 68 Ga-BNOTA-PRGD2 PET/CT to evaluate post-stroke angiogenesis. Trial registration: ClinicalTrials.gov identifier: NCT01656785; registered on 1 August 2012.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85792583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-04-01DOI: 10.4103/2468-5577.181236
Junhui Chen, Yu-hai Wang
Background: Animal studies have confirmed that statins have neuroprotective effects during and following a subarachnoid hemorrhage; however, the therapeutic effect of statins in humans remains controversial. The interpretation of data currently available on the clinical application of statins to spontaneous subarachnoid hemorrhage is limited by the small sample sizes used in the studies, making it difficult to draw valid conclusions regarding the multiple neuroprotective effects of statins. Thus, we propose to perform a randomized double-blind placebo-controlled parallel-group clinical trial to determine the effects of atorvastatin on spontaneous subarachnoid hemorrhage, apoptosis-related factors, and serum inflammatory factors in cerebrospinal fluid and to observe its neuroprotective effect mediated by relieving vasospasm. Methods/Design: This is a randomized parallel-group placebo-controlled double-blind clinical trial. This trial will recruit 300 patients with spontaneous subarachnoid hemorrhage from the Department of Neurosurgery, 101 st Hospital of PLA (Wuxi Taihu Hospital). These patients will be equally and randomly assigned to atorvastatin (40 mg/day) and placebo control groups. Outcomes will be evaluated at baseline, 3, 5, and 14 days after hemorrhage, and 6 months after discharge. The primary outcomes will be the results of computed tomography (CT) angiography combined with CT perfusion imaging and conventional CT. The secondary outcomes will be cerebrospinal fluid analysis, blood testing (tumor necrosis factor α, vascular endothelial growth factor, interleukin-6, and C-reactive protein levels), and the Hunt-Hess classification, the results of transcranial Doppler ultrasonography, and the scores on the Glasgow Coma Scale, the Glasgow Outcome Scale, and the National Institutes of Health Stroke Scale. Discussion: The results of this trial will provide data on the clinical application and neuroregenerative effect of atorvastatin in the acute stage of spontaneous subarachnoid hemorrhage. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-14005395) on 18 May 2014.
{"title":"Atorvastatin for treating spontaneous subarachnoid hemorrhage: study protocol for a randomized double-blind placebo-controlled trial","authors":"Junhui Chen, Yu-hai Wang","doi":"10.4103/2468-5577.181236","DOIUrl":"https://doi.org/10.4103/2468-5577.181236","url":null,"abstract":"Background: Animal studies have confirmed that statins have neuroprotective effects during and following a subarachnoid hemorrhage; however, the therapeutic effect of statins in humans remains controversial. The interpretation of data currently available on the clinical application of statins to spontaneous subarachnoid hemorrhage is limited by the small sample sizes used in the studies, making it difficult to draw valid conclusions regarding the multiple neuroprotective effects of statins. Thus, we propose to perform a randomized double-blind placebo-controlled parallel-group clinical trial to determine the effects of atorvastatin on spontaneous subarachnoid hemorrhage, apoptosis-related factors, and serum inflammatory factors in cerebrospinal fluid and to observe its neuroprotective effect mediated by relieving vasospasm. Methods/Design: This is a randomized parallel-group placebo-controlled double-blind clinical trial. This trial will recruit 300 patients with spontaneous subarachnoid hemorrhage from the Department of Neurosurgery, 101 st Hospital of PLA (Wuxi Taihu Hospital). These patients will be equally and randomly assigned to atorvastatin (40 mg/day) and placebo control groups. Outcomes will be evaluated at baseline, 3, 5, and 14 days after hemorrhage, and 6 months after discharge. The primary outcomes will be the results of computed tomography (CT) angiography combined with CT perfusion imaging and conventional CT. The secondary outcomes will be cerebrospinal fluid analysis, blood testing (tumor necrosis factor α, vascular endothelial growth factor, interleukin-6, and C-reactive protein levels), and the Hunt-Hess classification, the results of transcranial Doppler ultrasonography, and the scores on the Glasgow Coma Scale, the Glasgow Outcome Scale, and the National Institutes of Health Stroke Scale. Discussion: The results of this trial will provide data on the clinical application and neuroregenerative effect of atorvastatin in the acute stage of spontaneous subarachnoid hemorrhage. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-14005395) on 18 May 2014.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90067929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-04-01DOI: 10.4103/2468-5577.181239
J. Pei, Jun Wang, Qin-hui Fu, W. Dong, Xiao-xin You, Ming Dai, Yi Song
Background: Acupuncture is a relatively safe treatment for pain, and its analgesic effects have been confirmed. Electroacupuncture (EA) has been widely used to treat migraine because of its continuous and highly controllable stimulation. However, few rigorously designed randomized controlled trials have evaluated the efficacy of EA at the Hegu (LI4) and Taichong (LV3) acupoints in the treatment of migraine. Methods/Design: A prospective, single-center, single-blind randomized controlled trial will be performed at Longhua Hospital, Shanghai University of Traditional Chinese Medicine. Ninety-two patients with migraine will be randomly assigned to either undergo EA treatment (20 EA stimulations at the Hegu and Taichong acupoints; EA group, n = 46) or receive oral flunarizine (control group, n = 46). The primary outcome will be the Migraine Disability Assessment questionnaire score after 10 and 20 EA stimulations. The secondary outcomes will be the Medical Outcomes Study 36-item short form health survey score, Visual Analogue Scale score, and peripheral blood concentrations of plasma nitric oxide, calcitonin gene-related peptide, and nuclear factor-kappa B after 10 and 20 EA stimulations. Discussion: This trial is powered to investigate the efficacy of EA at the Hegu and Taichong acupoints in alleviating headache symptoms in patients with migraine and the interventional effects of this therapy on quality of life and social functioning to search for a more effective method of treating migraine. Trial registration: This trial protocol was registered at ClinicalTrial.gov (identifier: NCT02580968) on 30 July 2015. It was approved by the ethics committee of Longhua Hospital of Shanghai University of Traditional Chinese Medicine, China (approval No. 14401971300).
{"title":"Efficacy of electroacupuncture at the Hegu (LI4) and Taichong (LV3) acupoints in the treatment of migraine: study protocol for a randomized controlled trial","authors":"J. Pei, Jun Wang, Qin-hui Fu, W. Dong, Xiao-xin You, Ming Dai, Yi Song","doi":"10.4103/2468-5577.181239","DOIUrl":"https://doi.org/10.4103/2468-5577.181239","url":null,"abstract":"Background: Acupuncture is a relatively safe treatment for pain, and its analgesic effects have been confirmed. Electroacupuncture (EA) has been widely used to treat migraine because of its continuous and highly controllable stimulation. However, few rigorously designed randomized controlled trials have evaluated the efficacy of EA at the Hegu (LI4) and Taichong (LV3) acupoints in the treatment of migraine. Methods/Design: A prospective, single-center, single-blind randomized controlled trial will be performed at Longhua Hospital, Shanghai University of Traditional Chinese Medicine. Ninety-two patients with migraine will be randomly assigned to either undergo EA treatment (20 EA stimulations at the Hegu and Taichong acupoints; EA group, n = 46) or receive oral flunarizine (control group, n = 46). The primary outcome will be the Migraine Disability Assessment questionnaire score after 10 and 20 EA stimulations. The secondary outcomes will be the Medical Outcomes Study 36-item short form health survey score, Visual Analogue Scale score, and peripheral blood concentrations of plasma nitric oxide, calcitonin gene-related peptide, and nuclear factor-kappa B after 10 and 20 EA stimulations. Discussion: This trial is powered to investigate the efficacy of EA at the Hegu and Taichong acupoints in alleviating headache symptoms in patients with migraine and the interventional effects of this therapy on quality of life and social functioning to search for a more effective method of treating migraine. Trial registration: This trial protocol was registered at ClinicalTrial.gov (identifier: NCT02580968) on 30 July 2015. It was approved by the ethics committee of Longhua Hospital of Shanghai University of Traditional Chinese Medicine, China (approval No. 14401971300).","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87009357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-04-01DOI: 10.4103/2468-5577.181233
Jing Qiu, Huisheng Chen
Background: There is still a lack of effective treatments for acute ischemic stroke. Our pre-clinical studies suggest that ozone therapy administered by autologous blood transfusion is a convenient and safe treatment for ischemic stroke, and is popular with patients, but its therapeutic benefits are not clear. We hypothesized that ozone therapy administered by autologous blood transfusion for ischemic stroke is safe and effective, and propose a protocol for a prospective, multi-center, open-label, large-sample, parallel, randomized, non-blinded controlled trial. Methods/Design: This will be a multi-center, open-label, large-sample, parallel, randomized controlled trial. We intend to recruit 5,000 patients with acute ischemic stroke in 30 centers (including General Hospital of Shenyang Military Region, China). Patients will be randomly allocated to a control group (n = 2,500; conventional stroke therapy) or an ozone therapy group (n = 2,500; ozone therapy administered in addition to conventional therapy). The primary outcome will be a modified Rankin Scale score 0-2 at 90 days. Secondary outcomes will be National Institute of Health Stroke Scale score at 14 days, blood lipid and glucose concentrations and coagulation function at 14 days, and the incidence of post-stroke pneumonia, recurrent stroke and other vascular events in the first 90 days after stroke. Discussion: We hope that our results will illuminate the therapeutic benefits of ozone therapy administered by autologous blood transfusion for acute ischemic stroke. Trial registration: This trial was registered at Chinese Clinical Trial Registry (registration No. ChiCTR-ICR-15007093) on 18 September 2015.
{"title":"Efficacy and safety of ozone therapy administered by autologous blood transfusion for acute ischemic stroke: study protocol for a multi-center open-label large-sample parallel randomized controlled trial","authors":"Jing Qiu, Huisheng Chen","doi":"10.4103/2468-5577.181233","DOIUrl":"https://doi.org/10.4103/2468-5577.181233","url":null,"abstract":"Background: There is still a lack of effective treatments for acute ischemic stroke. Our pre-clinical studies suggest that ozone therapy administered by autologous blood transfusion is a convenient and safe treatment for ischemic stroke, and is popular with patients, but its therapeutic benefits are not clear. We hypothesized that ozone therapy administered by autologous blood transfusion for ischemic stroke is safe and effective, and propose a protocol for a prospective, multi-center, open-label, large-sample, parallel, randomized, non-blinded controlled trial. Methods/Design: This will be a multi-center, open-label, large-sample, parallel, randomized controlled trial. We intend to recruit 5,000 patients with acute ischemic stroke in 30 centers (including General Hospital of Shenyang Military Region, China). Patients will be randomly allocated to a control group (n = 2,500; conventional stroke therapy) or an ozone therapy group (n = 2,500; ozone therapy administered in addition to conventional therapy). The primary outcome will be a modified Rankin Scale score 0-2 at 90 days. Secondary outcomes will be National Institute of Health Stroke Scale score at 14 days, blood lipid and glucose concentrations and coagulation function at 14 days, and the incidence of post-stroke pneumonia, recurrent stroke and other vascular events in the first 90 days after stroke. Discussion: We hope that our results will illuminate the therapeutic benefits of ozone therapy administered by autologous blood transfusion for acute ischemic stroke. Trial registration: This trial was registered at Chinese Clinical Trial Registry (registration No. ChiCTR-ICR-15007093) on 18 September 2015.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80698896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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