A prospective double blind randomised controlled trial of Eupatorium perfoliatum 30 C in asymptomatic and mild symptomatic cases of COVID-19.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To assess the effectiveness of Homoeopathic medicine Eupatorium perfoliatum 30 C in preventing the progression of severity of the disease in the SARS-Cov-2 tested positive asymptomatic and mild cases of COVID-19.
研究概览
简要总结
This study is a prospective double blind randomized placebo controlled interventional trial to assess the effectiveness of Eupatorium perfoliatum 30 C, 2 or 4 globules (child/adult dose respectively) twice daily for five days as an add on therapy in 200 participants of asymptomatic and mild symptomatic cases of COVID-19 in one centre in India. The primary outcome will assess the effectiveness of Eupatorium perfoliatum 30 C in preventing the progression of severity of the disease in SARS -CoV 2 tested positive asymptomatic and mild cases of COVID-19 and the secondary outcome will assess the changes in Quality of Life (QoL) of the participants taking the medicine Eupatorium perfoliatum 30 C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects testing positive for SARS CoV-2 by RT-PCR, presenting with no symptoms or mild symptoms.
- •Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study.
排除标准
- •Cases of COVID-19 with clinical severity ranging from moderate to critical.
- •Pregnant and lactating females.
- •Subjects having uncontrolled and unstable co morbidity.
- •Immunocompromised subjects or those taking any kind of immunosupressive therapy.
- •COVIC-19 positive cases participating as subjects in other COVID-19 clinical trails.
- •Subjects having past history of allergy to any medicine that is part of the Homoeopathic intervention.
- •Other conditions, which in the opinion of the investigator, makes the patient unsuitable for enrollment or could interfere with his participation in, and completion of the protocol.
结局指标
主要结局
To assess the effectiveness of Homoeopathic medicine Eupatorium perfoliatum 30 C in preventing the progression of severity of the disease in the SARS-Cov-2 tested positive asymptomatic and mild cases of COVID-19.
时间窗: 3 month
次要结局
- 1. To assess the changes in Quality of Life (QoL) of the subjects using WHO QOL-BREF scale.(2. To assess the safety of Eupatorium perfoliatum 30 C drug by observing for adverse events.)