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A Comparative Clinical Study to Evaluate the effect of BlaQmax on Subjects with Post COVID-19 symptoms.

Not Applicable
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
Reduction in severity and duration of post covid symptomsTimepoint: Day 0, Day 28 , Day 84
Secondary Outcome Measures
NameTimeMethod
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
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