A double blinded randomized controlled clinical study to evaluate the efficacy of the Tulasi Ashwagandhadi Herbal Drops on Oxygen Saturation (SPO2) in the management of COVID-19 affected cases.
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To study the efficacy of Test product in elevation of SpO2 Concentration over Treatment Phase and Followup Phase in comparison to Baseline
研究概览
简要总结
Covid-19 is a pandemic health challenge that has affected millions of people around the world today. The present health setup is trying its level best to control and improve the condition in this regard. Its symptoms range from Mild to Severe which is at times even life threatening. The product is an Ayurvedic formulation where the combination of the herbs that are basically used in many Ayurvedic formulaitons that have been found to be useful in the management of symptoms namely Kasa (Cough), Shwasa (Dyspnea), Jwara (Hyperpyrexia), Shotha (Inflammation)etc. These symptoms are found in the mild cases of Covid-19 pandemic too especially in the mild cases.
Hence, the current study is planned to evaluate the safety and efficacy of the product in mild to moderate cases of Covid-19 affected to male and female subjects as an adjuvant to the general existing treatment protocol.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects who have been found to be COVID-19 positive The Oxygen Concentration level (SpO2) is between 85-95% observable during baseline screening.
- •Subjects in the age group 18-65 years (both the ages inclusive).
- •Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
- •Subjects with mild to moderate level of symptoms pertaining to COVID-19 Subjects willing to abide by and comply with the study protocol.
- •Subjects who have not participated in a similar investigation in the past three months.
排除标准
- •Subjects who have undergone invasive treatments like surgery or other treatment within 3 months before screening into the study.
- •Subjects having any active disease which may interfere in the study.
- •Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
- •Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
- •Subjects (females) who are pregnant or lactating A known history or present condition of allergic response/hypersensitivity to any ingredients and pharmaceutical products.
- •Chronic illness which may influence the respiratory state.
- •Subjects who had been part of any other clinical study within 3 months before screening into the study.
结局指标
主要结局
To study the efficacy of Test product in elevation of SpO2 Concentration over Treatment Phase and Followup Phase in comparison to Baseline
时间窗: Baseline, Day1, Day4, Day7, Day14 and Day21
次要结局
- To study the efficacy of Test product in SpO2 Conc elevation after Day1 Day4 and Day7 of treatment in comparison to baseline(Day1 vs baseline)