A phase II study to evaluate safety and effectiveness of IND02 Capsules in patients who are SARS-CoV2 positive patients with mild to moderate COVID-19 at COVID management centres offering Ayurvedic care.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/11/029328
- Lead Sponsor
- Indus Biotech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 118
1.Male or Female with >= 18 years and < 60 years of age, willing and able to provide written informed consent for participation in the study and ready to comply with the study procedures and schedule.
2.Patient with confirmed diagnosis for COVID-19, and who has tested positive for infection with SARS-CoV2 virus.
Note: COVID-19 infection confirmed by RT-PCR following ICMR/WHO protocol in <= 5 days prior to randomization in the study.
3.Patient is either requiring hospitalisation for COVID-19 or agrees to maintain a home or other quarantine as recommended by the study Investigator at the time of randomization in the study.
4.Patient with WHO Clinical Progression Scale score of 2 to 5
1.Patients with a known history of allergy or intolerance to Cinnamon.
2.Participation in another concurrent clinical trial for COVID-19 or in any other trial within the 6 months prior to this study enrolment.
3.Patients classified as severe or critical COVID-19 patients as per AYUSH guidelines.
4.Patients with pre-existing respiratory conditions, or with severe primary respiratory disease or other pneumonia, who may not be eligible for enrolment in the study as per the Investigatorâ??s opinion.
5.Patients with other serious diseases such as cancer, heart disease, stroke, disabilities, mental illnesses, etc., who may not be eligible for enrolment in the study as per the Investigatorâ??s opinion.
6.Patients requiring mechanical ventilation at screening.
7.Patients with uncontrolled and unstable comorbid conditions.
8.Immunocompromised individuals or patients who are already receiving immunosuppressant therapies.
9.Patients who are currently on or may require parenteral nutrition during the course of the study.
10.Female patients who are breastfeeding or pregnant at the time of enrolment in the study.
11.Female patients of childbearing potential who, within 4 weeks prior to study enrolment, did not use a highly effective method of contraception or do not agree to use a highly effective method of contraception throughout the study period.
12.Any medical or other condition that in the opinion of the Investigator would preclude the patientâ??s participation in the study.
13.Current abuse of alcohol; and current or past (last 12 months) abuse of drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Median time to recovery using WHO Clinical Progression Scale between the test and placebo groupsTimepoint: From date of randomization until 15 days of treatment and <br/ ><br>additional 7 days of follow-u <br/ ><br>
- Secondary Outcome Measures
Name Time Method