A double blind randomized controlled trial to assess safety and efficacy of Cap. IP in COVID-19 positive patients with mild to moderate severity for early recovery, in restoring respiratory health and in improvement in innate immunity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy of Cap. IP (500 mg) in boosting innate immunity of patients with COVID-19 infection in one months duration.
研究概览
简要总结
COVID -19 is a respiratory illness that has led to a pandemic, affecting more that 200 countries in the world. Due to sudden advent and rapid spread of infection, no antiviral drug has been found to be effective since its onset. (Tab. Favipiravir is approved though, it’s efficacy in population at large, in real-world setting is yet to be confirmed)
While there is no medicine for COVID-19 as of now, enhancing the body’s immunity should play an important role in maintaining optimum health and the IP (study drug) might possibly play an important role in enhancing immunity. The capsule contains ghana of Withania somnifera, Terminalia chebula, Tinospora cordifolia, Asparagus racemosus, Emblica officinalis etc.
Role of study drug as an antiviral will also be tested by frequent naso-pharyngeal and oro-pharyngeal swabs.
This is prospective, double blind study aims to assess the efficacy and safety of Cap. IP in the management of COVID 19 patients and also in boosting innate immunity. Secondary objectives are, to assess efficacy of Cap. IP in restoring respiratory health, in early recovery of patients and to assess safety of Cap. IP.
Trial Overview
Total 72 patients were enrolled in the study.1st patient was enrolled on 11 Aug 2020 and Last patient was enrolled on 3 Sep 2020.Follow up visits completed on 5 Oct 2020.
Protocol published under BMC.
1
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age > 18 years 2.All sexes 3.Case definitions for inclusion in the study will include mild to moderately severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVI19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr
- •Mild: Cases presenting with fever and/or upper respiratory tract illness (Influenza like Illness, ILI); Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%).
- •OR 4.Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS CoV-2 test result pending with a high clinical suspicion as defined by: Cough of more than 10 days duration OR 5.Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air, where no alternative explanation for respiratory symptoms can be given.
排除标准
- •1.Pregnant or lactating women 2.Symptoms of acute respiratory tract infection for more than seven days 3.More than 48 hours have elapsed between meeting inclusion criteria and enrolment 4.Subject is also a participant of any other clinical trial 5.Serious / long-standing co-morbid conditions.
结局指标
主要结局
Efficacy of Cap. IP (500 mg) in boosting innate immunity of patients with COVID-19 infection in one months duration.
时间窗: 1 month
次要结局
- Assessing safety of Cap. IP(1 Month)
- Efficacy of Cap. IP in early recovery of patients(1 Month)
- Efficacy of Cap. IP in restoring respiratory health(1 Month)