CTRI/2020/08/027499招募中2 期
“An Open Clinical Trial to Evaluate the Safety & Efficacy of Siddha Sastric Medicines – Fixed Regimen in COVID-19 Positive asymptomatic mild or moderate cases with reference to the Siddha guidelines of COVID-19 management Ministry of AYUSH Govt of India at SIDDHA COVID CARE CENTER Sri Arcot Mahalakshmi Nursing College Campus Vilappakkam Ranipet District Tamilnadu
MrsDivyadharshini IAS1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年5月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in Viral load of SARS-CoV-2 at the end of treatment
研究概览
简要总结
We are planning to conduct a clinical trial to know the safety and efficacy of siddhha medicine fixed regimen in covid positive patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •S.NoParameter 1.Adult Male/Female subjects above the age of 18 years 2.COVID -19 Positive as determined by RT-PCR 3.Willing to provide written/digital informed consent. 4.COVID.
- •19 Positive with no clinical signs 5.COVID.
- •19 Positive with mild symptoms – Sneezing, Cough, Sore Throat, Throat Pain, Malaise, Tiredness, Fever, loss of smell, loss of taste 6.COVID.
- •19 Positive with moderate symptoms – Fever with cough, breathlessness but respiratory rate <24 per minute and Oxygen saturation > 95% at rest.
排除标准
- •S. NoParameter 1.Pregnant and Lactating females 2.COVID.
- •19 Positive with Severe symptoms – Respiratory distress (>24 breath per minute), Oxygen saturation < 95% at rest, Respiratory failure, Need of Mechanical Ventilation, Septic shock, Non respiratory organ failure 3.Chronic Renal Failure requiring dialysis (eGFR < 30) 4.Known cases of uncontrolled Diabetes (>9% HbA1c) 5.Known cases of stage 3 Hypertension (> 160/100 mmHg) 6.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening 7.Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. 8.Subjects taking Steroid treatment and or any kind of immunosuppressive therapy 9.Subjects who are participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.
- •Subjects with bleeding disorders and severe anemia (Hb <7 g/dL).
结局指标
主要结局
Reduction in Viral load of SARS-CoV-2 at the end of treatment
时间窗: one week
Reduction in clinical symptoms like fever, cough and breathlessness
时间窗: one week
(1.Fever: ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic ;
时间窗: one week
(2. Respiratory rate - ≤24/minute on room air;
时间窗: one week
(3.Cough - mild or absent on a patient reported scale (cough symptoms score ≤ 2 points)
时间窗: one week
次要结局
- Reduction in incidence of complications(Reduction in hospital time)
研究者
研究点 (1)
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