CTRI/2022/05/042782尚未招募不适用
A Randomized, Multi Center, Double Blinded, Placebo-Controlled, Parallel-Group, Comparative Clinical Study to Evaluate the effect of BlaQmax on Subjects with Post COVID-19 symptoms.
Akay Natural Ingredients Pvt Ltd1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年2月6日
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Reduction in severity and duration of post covid symptoms
研究概览
简要总结
This is a double blind, randomized (1:1), placebo controlled, parallel group clinical study. Subjects having at least three of the Post COVID-19 symptoms [ meeting all inclusion and no exclusion criteria after signing a written informed consent will be enrolled in the study. The subject will undergo laboratory assessment, cognitive function tests, biomarker assessments, respiratory function assessment and fatigue assessment and other questionnaire based assessments at different time points The study is planned to be conducted in 3 visits over a period of 84 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •COVID-19 patients with confirmed diagnosis based on a positive ICMR recognized SARS-Cov-2 test performed ≥ 4 weeks and ≤ 12 weeks.
- •Subjects having at least three of the Post COVID-19 symptoms including: [fatigue, headache, respiration problems (dyspnea or polypnea, cough), cognitive disorders (attention, memory, anxiety and depression), pain in joints, muscles and chest, gastrointestinal issues (diarrhea, nausea/vomiting, abdominal discomfort), sleep problems, cardiac issues (chest pain, heart palpitations, tachycardia, arrhythmia].
- •COVID-19 patients discharged after hospital admission.
- •4.If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable for past 3 months prior to baseline and throughout the study.
- •Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •Asymptomatic COVID-19 subjects
- •Post COVID-19 patients with symptoms longer than 3 months.
- •Subjects suffering from any uncontrolled chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart and liver disease) or other underlying severe diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition)
- •History of any Immunodeficiency disease, Allergy, medication or supplement use that influences the immune system.
- •5.Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption.
结局指标
主要结局
Reduction in severity and duration of post covid symptoms
时间窗: Day 0, Day 28 , Day 84
次要结局
- Change in Questionnaire based assessments(Day 0, Day 28 , Day 84)
- Change in Cognitive parameters(Day 0, Day 84)
- Change in hematolgical and biochemical parameters(Day 0, Day 84)
- Change in Biomarkers(Day 0, Day 84)
研究者
研究点 (1)
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