Evaluation of an Ayurvedic formulation in clinical recovery of COVID-19 infected patients: A double blind randomized study
Phase 3
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/10/037423
- Lead Sponsor
- Sriveda Sattva Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
Inclusion Criteria
Age 21to 75 years
b) SymptomaticCOVID-19 infected patients with or without comorbidities
c) Reported to OPD within three days of onset of symptoms
d) Willing to take AYUSH treatment
Exclusion Criteria
Not willing to give consent/ participate in the clinical trial
b) Age less than 18 years or more than 75 years
b) Patients with chronic comorbidities like diabetes, chronic heart conditions and HIV/AIDS
c) Pregnant and Lactating mothers
d) Patients on immunosuppressive therapy
e) SARS-CoV-2 infected patients with oxygen saturation less than 90% or those in IC
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The patients were assessed for improvement from COVID-19 based on their RT-PCR negative results. The primary outcome was the rate of recovery based on viral load reduction, RT-PCR negativity rate.Timepoint: Day 0,3,5,7, 10(if required)
- Secondary Outcome Measures
Name Time Method Secondary outcomes included clinical improvement among the patients as evaluated by the CBC, CRP. <br/ ><br> <br/ ><br>To evaluate the safety of the drug by assessing LFT and KFTTimepoint: Day 0, 5/exit