CTRI/2021/05/033543
Completed
Phase 2
A study to assess efficacy and safety of Ayurvedic formulation [CIM-MEG19] as an add-on therapy to the standard care in mild to moderate COVID 19 positive to combat the severity / recovery of symptoms / disorders - CSIR-CIMAP-CIM-MEG19
Ms Meghdoot Gramodyog Sewa Sansthan0 sites80 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ms Meghdoot Gramodyog Sewa Sansthan
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •COVID\-19 RT\-PCR positive patients
- •Male or Female of age 18\-70 years
- •Subject is ready to give written Informed consent
- •Can take oral medicines
- •Mild to moderate grade of the disease. Mild\- Upper respiratory tract symptoms of fever with or without shortness of breath or hypoxia. Moderate\- Any one of\- 1\. Respiratory rate more than 24/min, breathlessness 2\. SpO2: 90\-93% on room air. 3\. PaO2 /FiO2 : 200\-300/g) as per AIIMS/ ICMR\-COVID\-19 National Task Force/Joint Monitoring Group recommendations
- •Not participating in any other interventional drug study g) Agree to follow all study procedures
Exclusion Criteria
- •Known sensitivity to the ingredients of IP
- •Bleeding haemorrhoids
- •Pre\-existing GI symptoms like nausea or vomiting
- •Presence of acute hypoxic respiratory failure
- •Intensive care unit (ICU) stay\-
- •Patients who need mechanical ventilation
- •Category 6 or 5 based on modified 7\-category ordinal scale of clinical status
- •Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely Severe infection
- •Pregnant or lactating women
- •For Arm A: subjects receiving any antiviral treatment for Covid (like Favipiravir, Remdesivir)
Outcomes
Primary Outcomes
Not specified
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