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Introduction: Parikartika resembles fissure‑in‑ano which is one of the common painful disease among the anorectal disorders. Ksharasutra which is a para‑surgical procedure is effective in the management of Parikartika.

Aim: To compare the efficacy of Apamarga Ksharasutra and open lateral internal sphincterotomy (OLIS) in the management of Parikartika (chronic fissure‑in‑ano).

Materials and methods: Total 30 patients having signs and symptoms of Parikartika (chronic fissure‑in‑ano) were selected and randomly divided into two groups. In Group A (n = 15), Ksharasutra ligation after anal stretching was carried out while in Group B (n = 15), OLIS with excision of skin tag was carried out under local anesthesia or spinal anesthesia. Relief in postoperative symptoms and complications if any was recorded for 4 weeks and follow‑up was done for the period of 1 month.

Results: In both the groups, significant results were obtained, but the difference among groups was statistically insignificant. Duration required for relief in postoperative pain, bleeding, swelling, and wound healing was found to be more in Group A (Ksharasutra) than Group B (OLIS).

Conclusion: OLIS provided better results compared to Ksharasutra ligation in the management of Parikartika (chronic fissure‑in‑ano).

Background: Katigraha (low back pain) is a condition where low back is afflicted either with Vata or Sama Vata (Vata involved with the toxins released due to altered digestion and metabolism) and present with symptoms such as pain with stiffness. About 60%-80% population in India suffer from this condition. Upanaha Sweda (poultice) is one of the Swedana (sudation) treatment modalities mentioned for Katigraha. As Sama (affected with toxins released from impaired digestion) and Nirama (without toxins) are two stages of Katigraha, hence, the specific type of Upanaha is required for such condition.

Aims and objective: The study was conducted to evaluate the effect of Upanaha Sweda in Katigraha (low back pain) as per the presentation of stages of Ama.

Materials and methods: Selected patients were categorized into two groups. In group A, patients having Samaja Katigraha, were given Panchakoladi Upanaha once a day till it became Niramaja, then shifted to Godhumadi Upanaha for 7 days and patients who had Niramaja Katigraha, Godhumadi Upanaha was used once a day for 7 days. In group B Godhumadi Upanaha was used once a day for 7 days irrespective of stages. Subjective parameters assessed were pain in the low back, stiffness, and Oswestry Disability Index (ODI) was also used. The Mann-Whitney U test and Wilcoxon signed‑rank test were used to assess results.

Results: Patients who were treated considering the Sama and Nirama phases had 78.88% better results in relieving pain, stiffness, and in ODI change than the patients treated without considering the phases.

Conclusion: The present study showed significant results in both the groups, but patients treated as per stage wise treatment showed better effect in treating Katigraha than the patients treated with out considering the stage.

Background: Metabolic syndrome (MS) is a cluster of obesity, hypertriglyceridemia, impaired glucose tolerance, and insulin resistance. The sedentary lifestyle settles on the phenotypical expression of a genetically acquired trait in an obese person. Weight control and a healthy lifestyle remain primary and effective strategies for prevention and management of the MS. The lifestyle modifications mentioned for Santarpanjanya (disorders due to over nutrition) diseases and Arogyavardhini compound that can improve metabolism and reduce weight were selected for a present clinical trial to assess and compare their efficacy in the management of the MS.

Materials and methods: Seventy‑five patients were registered for the trial and randomly divided into two groups. Patients were treated with lifestyle modification with and without Arogyavardhini compound for 8 weeks.

Results: Thirty‑five patients in each group could complete the course of treatment. Lifestyle modification alone and with Arogyavardhini compound resulted in 1.32% and 3.06% decrease in waist circumference, 5.81% and 18.03% decrease in serum triglycerides, 4.43% and 6.89% decrease in systolic blood pressure, 3.82% increase and 2.48% decrease in fasting blood sugar, 9.13% and 5.56% increase in high‑density lipoprotein, respectively. The decrease in waist circumference, systolic blood pressure was statistically significant in the both groups.

Conclusion: Arogyavardhini compound, along with lifestyle modification was found more effective than lifestyle modification alone in the management of MS.

Introduction: WHO's International Clinical Trials Registry Platform (ICTRP) has 17 primary registries that collect the information on the minimum set of items of trial information that appear in the register and these registries are also endorsed by the International Committee of Medical Journal Editors.

Objective: The objective of this study is to describe the profile of all the primary registries including Clinical Trial Registry‑India (CTRI), through features such as magnitude, domain of registration, flagging, audit trail, language, mandatory requirements, and result disclosure.

Methodology: The profiling of all registries was based on countries and zones, year of establishment, registrant, flagging, conflict of interest, language, documents, result disclosure, type of study, mode of registration, mandate of registration, quality check method, individual patient data statement and translation of content facility. The mode of search used was online which included advanced search, basic search and also from the audio/video manual on their website.

Results: There are 17 primary registries of ICTRP, the first one International Standard Randomised Controlled Trial Number (ISRCTN) of England being initiated in year 2000 and the most recent being Lebanese registry, in September 2019. The trials registered with these registries range from 301 in Cuba to 53972 in European union's EU Clinical Trials Register. The primary registries in WHO registry network are diverse in functionalities and practices. The characteristics of online registers vary in content and features and to achieve coordinated level of data quality, across all the different registries and to keep a balance in standards of the data collected and validation of that data, the registries are adhering to the minimum data set items laid down by ICTRP.

Conclusion: The very process of registering the clinical studies helps in promoting the research methods and also raising the standards of research, especially among young researchers. It also helps in reducing the duplicity of research.

Introduction: Bacnil capsule is a poly‑herbomineral formulation used to treat gastroenteritis. It contains many potential drugs derived from plant sources and Bhasma (calcined fine powder) preparations.

Aims: The study was designed to ascertain the safety of bacnil capsule orally in Charle's Foster albino rats.

Materials and methods: As per the Organization for Economic Cooperation and Development (OECD) 425 protocol oral acute toxicity study, bacnil capsule was administered orally once only at the dose of 2000 mg/kg in rats. For repeated dose toxicity study, AYUSH 170 and OECD 407, it was administered at three dose levels, Therapeutic doses (TED) (196.2), TED × 5 (981) and TED × 10 (1962) mg/kg/day orally for 28 days in albino rats followed by a 15‑day recovery period only on TED × 10 dose level.

Observation and results: Bacnil at the oral dose of 2000 mg/kg did not produce any toxicity or mortality in albino rats. Repeated dose 28‑day oral toxicity revealed that test formulation did not produce any significant change in serum biochemical, hematological, and histopathological parameters at therapeutic dose level. Mild‑to‑moderate pathological changes were observed in the various serum biochemical and cytoarchitecture of the liver, heart, kidney, and stomach at a dose of 10 TEDs; however, the same was reversed after discontinuation in the recovery test.

Conclusion: Bacnil at 196.2 mg/kg/day is safe at the therapeutic dose level in albino rats.

Introduction: Curcumin, a component of turmeric (Curcuma longa L.), is a molecule of multitude of medicinal properties. Although curcumin has found a place in the treatment of gingival and periodontal diseases, there are no reported cytotoxicity studies on the cells of clinical significance (i.e., periodontal ligament [PDL] fibroblasts).

Aims: The objective of this research was to assess the in vitro cytotoxicity of curcumin against human PDL fibroblasts.

Materials and methods: Human PDL fibroblasts from premolar teeth were cultured and used for cytotoxicity tests from healthy children presented for orthodontic extractions. Test concentrations of curcumin (100%, 50%, and 25%) were prepared by diluting 95% curcumin with di‑methyl‑sulfoxide and added to 96‑well microtiter plate (in triplicate) containing the fibroblast culture (approximately 2 × 104 cells/well). Fibroblast cells without treatment (without curcumin) acted as a control group. The viability of cells after 48 h of incubation at 37°C in a humidified atmosphere of 5% CO₂ and 95% air was ascertained by the 3‑(4, 5‑dimethyl‑thiazol‑2‑yl)‑2, 5‑diphenyl‑tetrazolium bromide (MTT) assay. The viability of PDL fibroblast cells of experimental wells was expressed relative to that of control, in terms of change in the color intensity. Absorbencies were recorded at 450 nm on a microplate reader with background subtraction at 620 nm. The cell viability at various concentrations of curcumin against the PDL fibroblasts was calculated as mean absorbance (optical density) and percentage values.

Results: Cell viability of PDL fibroblasts to 100%, 50%, and 25% curcumin concentration was 111.75%, 112.50%, and 114.40%, respectively.

Conclusions: No in vitro cytotoxicity was detected for curcumin against human PDL fibroblasts, at any of the concentrations used (100%, 50%, and 25%) by MTT assay at the end of 48 h.

Background: Condition of insomnia may not be a life-threatening illness, but it has tendency to damage the person's daily life. In the current era of modernization, most of the person are is suffering from stress either it is personal or professional. Stress may cause sleeping problems or make existing problems worse. Sattvavajaya Chikitsa is a specialized type of treatment influencing the psychological aspect of body. It can be applied in the form of Yogic practices and other mind control techniques. With this research interest, the present study has been undertaken to assess the efficacy of the Sattvavajaya Chikitsa in the form of relaxation techniques (RT) and Guda Pippalimula Churna in Anidra (insomnia).

Objectives: The objective of the study was to evaluate the efficacy of Sattvavajaya Chikitsa in the form of RT and Guda Pippalimula Churna in Anidra.

Materials and methods: The study was an open-labeled randomized clinical trial in which sixty patients having symptoms of Anidra belonging to the age group of 20-60 years were enrolled and received Sattvavajaya Chikitsa (RT) and Guda Pippalimula Churna orally in 2gm dosage with jaggery for 28 days. The assessment of symptoms was done on the basis of relief in the scores given to signs and symptoms according to their severity.

Results: Both the groups showed significant results in chief as well as associated symptoms of disease. Regarding overall effect of therapy in both the groups, marked improvement is high followed by moderate improvement. No adverse reactions were documented.

Conclusion: Sattvavajaya Chikitsa and Guda Pippalimula Churna are effective on Anidra, but Sattvavajaya Chikitsa was found more effective in reducing Manasa symptoms such as Chinta (tension), Bhaya (fear) and Krodha (anger).

Background: Prevalence and incidence of oral mucositis (OM) are rigorously increasing and there is no effective treatment. The herbal formulation "HTOR-091516" containing Curcuma longa, Triphala and honey were evaluated for the treatment of OM.

Aim: The aim of this study was to evaluate the safety and efficacy of HTOR-091516, employing cellular model, human gingival fibroblasts-1 (HGF-1), and 5-fluorouracil (5-FU)-induced mucositis model in rats.

Materials and methods: The cell viability was assessed using 3-(4, 5-dimethylthiazolyl-2)-2, 5-diphenyltetrazolium bromide (MTT) assay and the inhibitory effect of HTOR-091516 on tumor necrosis factor-alpha (TNF-α) was evaluated using TNF-α bioassay in lipopolysaccharides-induced HGF-1. 5-FU and glacial acetic acid were used to induce OM in rats. Animals were divided into two groups, group 1 served as mucositis control and group 2 was treated with HTOR-091516 at the dose of 200 μl and TNF-α was estimated in plasma samples.

Results: The in vitro safety of HTOR-091516 was evaluated in reconstructed human oral epidermis and was found to be nontoxic and exhibited concentration-dependent TNF-α inhibition in HGF-1. The treatment with HTOR-091516 reduced mucositis scores and mortality rate and also decreased the plasma TNF-α level.

Conclusion: The present data indicate that HTOR-091516 is effective in the treatment of OM.

Background: Agnikarma (therapeutic heat burns) and Raktamokshana (therapeutic bloodletting) are the treatment modalities mentioned in Ayurveda texts to combat the clinical condition of Sandhigata Vata (osteoarthritis) which occurs due to provoked Vata Dosha and/or Vyana Vayu overlapped with Kapha. Lumbar spondylosis is a degenerative disorder presenting with lower back pain, stiffness, numbness, difficulty in movement etc., with evidence of osteophytes and reduced disc height in plain film radiograph.

Aims and objectives: The aim of the study was to evaluate the role of Agnikarma and Raktamokshana in the management of Kati Sandhigata Vata (lumbar spondylosis).

Materials and methods: After obtaining CTRI registration, total 32 cases of lumbar spondylosis were registered and allocated into two groups by simple random sampling method. 16 patients were treated with Agnikarma with Panchadhatu Shalaka (group A) and 16 patients were treated with Raktamokshana by modified Shringa Yantra (group B).

Results: The result was assessed using the Wilcoxon signed-rank test and paired t-test. Significant results were observed in relieving lower back pain, stiffness, numbness and painful movements in both the groups.

Conclusion: Agnikarma was found more effective in relieving pain and numbness in lower back and Raktamokshana was found better in relieving pain and stiffness of lower back.