治疗cov -2感染(COVID-19)的随机对照临床研究

Y. Dound, M. Sagar, Lik, S. Suryavanshi, R. Sehgal, A. Naik
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引用次数: 0

摘要

新冠肺炎疫情给全球研究人员提出了巨大挑战。无法获得任何疫苗或药物使情况恶化,并已成为现代最严重的流行病。保持科学的原理和硅研究的结果,研究人员在Shreepad Shree Vallabh SSV植物制药(SSV)已经开发出含有天然成分的配方,即姜黄素,维生素C,维生素K2-7和l -硒代蛋氨酸。目的:评价库洛维他在COVID-19治疗中的作用及其与卫生和家庭福利部(MOHFW)标准治疗方法的耐受性。研究设计和方法:在一项随机、两组比较研究中,于2020年8月和9月从印度马哈拉施特拉邦纳西克的Radiant Plus医院招募了COVID-19阳性患者(n=200)。入组患者分别给予库瑞维他500 mg片剂,每日2次,或给予卫生部设计的标准治疗方案,疗程10天。评估患者口腔温度下降情况;咳嗽和呼吸窘迫的SpO2和VAS评分。通过评估白细胞介素-6、同型半胱氨酸、d -二聚体、铁蛋白和C反应蛋白等标志物来评估其潜在机制。结果:在cureqovita组中,所有受试者的体温在两天内显著降低至发热水平,并保持发热直到研究结束。而在标准治疗组,所有受试者的体温在4天后降至发热阶段,此后一直保持发热状态直到研究结束。与标准治疗组相比,在基线时升高的血清白介素-6、同型半胱氨酸、二聚体、铁蛋白和c反应蛋白水平在10天内明显下降到正常范围内。结论:curecovitaatm首次显示出对COVID-19阳性患者的有效治疗,并在开始治疗48小时内改善免疫力。在所有接受治疗的患者中,CureqovitaaTM耐受性良好,没有任何副作用。
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A Randomized, Comparative Clinical Study to Evaluate the Activity of CureqovitaaTM Formulation for Management of SARS-COV-2 Infection(COVID-19)
COVID-19 outbreak has put forward a huge challenge in front of researchers across the globe. Non availability of any vaccine or drug has worsened the situation and it has become a worst pandemic of modern times. Keeping scientific rationale and results of in silico studies, Researchers at Shreepad Shree Vallabh SSV Phytopharmaceuticals (SSV) have developed formulation containing natural ingredients viz Curcumin, Vitamin C, Vitamin K2-7 and L-Selenomethionine. Objective: To evaluate role of CureqovitaaTM in the management of COVID-19 and its tolerability in comparison with standard treatment available from Ministry of Health and Family Welfare (MOHFW). Study design and methodology: In a randomized, two arm, comparative study, COVID-19 positive patients (n=200) were enrolled during the month of August and September 2020 from Radiant Plus Hospital, Nashik, Maharashtra, India. The enrolled patients were administered either CureqovitaaTM 500 mg tablets twice daily or given standard treatment protocol designed by MOHFW for 10 days. The patients were evaluated for decrease in oral temperature; SpO2 and VAS score for cough and respiratory distress. The underlying mechanism was assessed by evaluating markers such as Interleukin-6, Homocysteine, D-dimer, Ferritin and C Reactive Protein. Results: In the CureqovitaaTM group, within two days, temperature reduced considerably to afebrile level in all the subjects and remained afebrile till end of study. While in the standard treatment group, temperature reduced to afebrile stage in all the subjects by 4 days and there after remained afebrile till end of study. The elevated levels of serum Interleukin-6, Homocysteine, Di-dimer, Ferritin and C-Reactive Protein at baseline dropped considerably within normal limits within 10 days in the CureqovitaaTM group in comparison to standard treatment group. Conclusion: CureqovitaaTM has shown for the first time to be useful in management of COVID-19 positive patients along with improvement in the immunity, within 48 hours of starting treatment. CureqovitaaTM was well tolerated without any side effects in any of the patients treated.
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