CTRI/2020/11/029328
Completed
Phase 2
A prospective, interventional, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of IND02 capsules (Cinamuneâ?¢) in SARS-CoV2 positive patients with mild to moderate COVID-19, managed as per the Government of India COVID-19 management guidelines, at COVID-19 management centres offering integrated Ayurvedic care.
Indus Biotech Limited0 sites118 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Sponsor
- Indus Biotech Limited
- Enrollment
- 118
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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