CTRI/2021/07/034520Other3 期
Evaluation of Clinical Efficacy of Tab. AOIM – Z in managing after-effects of COVID – 19 infection – An Open Labelled, Single Arm, Prospective, Exploratory Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- a) Improvement in symptoms of Post COVID-19- such as Cough, Fatigue, Shortness of breath, Chest pain, Anxiety and olfactory and gustatory dysfunction
研究概览
简要总结
This study is terminated due to some unavoidable circumstances.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female participants between the age group of 18 to 60 years (both inclusive), Participants with history of positive RT-PCR (Not less than 2 weeks to rule out active infection),3.Participants with symptoms of Post COVID-19 syndrome such as cough, fatigue, shortness of breath, anxiety, olfactory and gustatory dysfunction, Participants who are ready to provide written informed consent and who are ready to voluntarily participate and abide to the protocol requirements.
排除标准
- •Pregnant and Lactating females, Participants hospitalized or in institutional quarantine, Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening, Participants having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc., Participants taking steroid treatment and or any kind of immunosuppressive therapy, Participants participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study, Other conditions, which in the opinion of the investigators makes the subject unsuitable for enrolment or could interfere in adherence to of the study protocol.
结局指标
主要结局
a) Improvement in symptoms of Post COVID-19- such as Cough, Fatigue, Shortness of breath, Chest pain, Anxiety and olfactory and gustatory dysfunction
时间窗: Day 0, Day 45, Day 90
f) Quality of life as assessed by Q-LES-Q-SF questionnaire
时间窗: Day 0, Day 45, Day 90
b) Improvement in Respiratory Function (FVC & FEV1)
时间窗: Day 0, Day 45, Day 90
c) Improvement in CRP levels
时间窗: Day 0, Day 45, Day 90
e) Improvement in distance covered in 6-min walk test
时间窗: Day 0, Day 45, Day 90
d) Improvement in SpO2 (sitting & after 6-min walk test)
时间窗: Day 0, Day 45, Day 90
次要结局
- a)Incidence of re-infection of COVID-19, inquired at visits and weekly telephonic follow-up(b)Incidence and severity of allergic conditions (non-infective) leading to sneezing, running nose, sore throat etc, inquired at visits and weekly telephonic follow-up)
研究者
研究点 (1)
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