Double blind, placebo controlled, multi-centric,cluster randomized study to evaluate the efficacy of Homeopathic medicines inthe prevention of COVID-19 in Quarantined or Exposed Individuals
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- a. Number of people turning symptomatic
研究概览
简要总结
In the wake of the COVID19 outbreak, everyone across globe is suffering. Researchers are trying hard to evaluate the remedies to fight against COVID19. Immunity boosting options that provides enhancement of natural defense can be useful. We all know that Prevention is better than cure and currently there is need for prevention of COVID19 illness. Homeopathy medicines are used in past for prevention/ immune boosting measure for influenza illness (other viral and bacterial infection). Ministry of AYUSH has also recommended the use of homeopathic medicines as preventive for the risk groups. The homeopathic medicines used in the formula have been prepared as per the directives of Homeopathy Pharmacopeia of India, under the Ministry of AYUSH, Government of India. The medicines are essentially free form toxic effects. This study plans to evaluate the efficacy of Homeopathic Covid19 Formula in quarantine individuals.
A randomized double-blind, placebo-controlled study was conducted in a quarantine facility. Out of 4,497 quarantined individuals - 2,343 were screened, 2,294 were enrolled and 2,233 completed the trial. Medicines used: Arsenicum album 30c, Bryonia alba 30c, Coronavirus nosode CVN01 30c, Camphora 1M as well as placebo. Bryonia alba 30c and CVN01 30c showed higher efficacy signals compared to placebo. The other medicines did not show any signals as compared to the placebo. The recovery time was shorter in the subjects using Coronavirus nosode CVN01 30c as compared to Bryonia alba 30c, which was mildly significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Quarantined individuals Covid19 exposure risk groups (For example, police, hospital staff, etc.) The participant is willing and able to give informed consent for participation in the study Agrees not to self-medicate with potential antivirals.
排除标准
- •Subjects who are detected SARS-CoV-2 positive at baseline ii.
- •Inability to be followed up for the trial period iii.
- •Subjects who are scheduled to receive any other investigational drug during the study.
结局指标
主要结局
a. Number of people turning symptomatic
时间窗: Baseline, week 2 and week 4
Number of people turning Covid19 positive
时间窗: Baseline, week 2 and week 4
c. Number of people recovering after turning positive
时间窗: Baseline, week 2 and week 4
d. Number of deaths, if any, if get infection
时间窗: Baseline, week 2 and week 4
次要结局
- a. The duration of the period of illness for those get infected(b. The severity of the illness of those who get infected.)