A Comparative Clinical Study to Evaluate the effect of BlaQmax on Subjects with Post COVID-19 symptoms.
- Registration Number
- CTRI/2022/05/042782
- Lead Sponsor
- Akay Natural Ingredients Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. COVID-19 patients with confirmed diagnosis based on a positive ICMR recognized SARS-Cov-2 test performed >= 4 weeks and <= 12 weeks.
2. 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].
3. 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.
5. Must be willing and able to give informed consent and comply with the study procedures.
1. Asymptomatic COVID-19 subjects
2. Post COVID-19 patients with symptoms longer than 3 months.
3. 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)
4. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in severity and duration of post covid symptomsTimepoint: Day 0, Day 28 , Day 84
- Secondary Outcome Measures
Name Time Method Change in BiomarkersTimepoint: Day 0, Day 84;Change in Cognitive parametersTimepoint: Day 0, Day 84;Change in hematolgical and biochemical parametersTimepoint: Day 0, Day 84;Change in Questionnaire based assessmentsTimepoint: Day 0, Day 28 , Day 84