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

Not yet recruiting

• Conditions: With History of post covid complications

• Registration Number: CTRI/2022/05/042782
• Lead Sponsor: Akay Natural Ingredients Pvt Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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.

Exclusion Criteria

• Asymptomatic COVID-19 subjects 2.
• 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) 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 symptoms	Day 0, Day 28 , Day 84

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

BGS Global Institute of Medical Sciences and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

BGS Global Institute of Medical Sciences and Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Jayashree S Seeri

Principal investigator

9482164779

drjayashree.ct@gmail.com