To study the clinical effect and molecular mechanisms of herbal formulation in combating Covid-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2022/09/045632
- Lead Sponsor
- All India Institute of Ayurveda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subject aged 20 to 60 years (both inclusive) of both gender
Subject with SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR)
Subject with mild manifestations of COVID-19 (WHO ordinal score 1 or 2)
Subject with oxygen saturation � 95% as measured by pulse oximetry
Subject with initial onset of signs/symptoms attributable to COVID-19 for �5 days prior to the day of randomization
Subject with ability to swallow and retain oral medication
Subject with willingness and ability to comply with trial and follow-up procedures
Subject with ability to understand the nature of this trial and give written informed consent
Subject with RT-PCR positive COVID-19 with no symptoms
Subject currently hospitalized or expected to need hospitalization for COVID-19 within 48 hours of randomization
Subject in which the present episode of infection is a recurrence or reinfection of COVID-19 (within 90 days)
Subject having stage 2 hypertension (systolic blood pressure level > 160 mmHg and diastolic blood pressure of > 100 mmHg)
Subject using more than 3 anti-hypertensive drugs
Subject hospitalized for decompensated congestive heart failure in the last 12 months
Subject having HbA1c > 9.0%
Subject having Class 3 obesity (BMI � 40)
Subject with aspartate aminotransferase (AST)/alanine transaminase (ALT) more than 3 times the upper limit of normal reference range
Subject who is pregnant, lactating or planning pregnancy during the study period
Subject of childbearing potential, unwilling to use highly effective contraception during their participation in the trial and for 2 weeks after study completion
Subject with a history of receiving any allopathic or alternative (herbal) medication, any antiviral drugs with reported activity against COVID-19 (ivermectin, favipiravir, hydroxychloroquine, lopinavir, and remdesivir) or warfarin therapy for the present COVID-19 episode within 7 days before enrolment
Subject on steroid or other immunosuppressive medication or having treatment within the last 3 months
Subject with unstable or life-threatening systemic diseases like immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, carcinoma, respiratory failure and end stage renal disease
Subject with a platelet count <100,000/�¼L or who have received a platelet transfusion in the 5 days prior to randomization.
Subject having hypersensitivity or other contraindication to any of the components of the study interventions as determined by the principal investigator.
Subject with conditions that could limit gastrointestinal absorption of tablet contents.
Subject who is already participating in another trial or have received an experimental drug or have used an experimental medical device within 30 days prior to the planned start of procedure
Subject unlikely to comply with the procedure or complete the scheduled follow up visit, in the opinion of principal investigator
Employee of the principal investigator or study center with direct involvement in the proposed study or other studies under the direction of that principal investigator or study center
Other indication-based exclusion, in opinion of principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to negative COVID-19 RT-PCR test in subjects having RT-PCR confirmed mild COVID-19 (WHO 8-point Ordinal Scale Score 1 or 2)Timepoint: Day-3to-1 Day8to9 Day11-12 Day15 Day30 or early termination visit
- Secondary Outcome Measures
Name Time Method