Study to evaluate the effect of two herbal drugs NIFAy.C-19(CONTAZAP)and AYUSH 64 in corona patients.
Phase 3
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/01/030169
- Lead Sponsor
- ational Innovation FoundationIndia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1.Patients tested positive for SARS-CoV2 virus infection
2.Patients having one or more symptoms of mild to moderate category of COVID-19 infection.
3 Patients of either sex.
4.Age: 18 years to 80 years.
5.Patients who can take oral medicines
6.Patients who are ready to give consent to participate in the study.
Exclusion Criteria
1.Patients having severe symptoms of COVID-19 infection.
2.Age below 18 years and more than 80 years.
3.Patients requiring intubation or mechanical ventilators.
4.Pregnant and lactating women.
5.Oncological disease and other systematic un-controlled condition
6.RFT >= 2.5 times of the upper limit.
7.Patients participating in other trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a) Mean time (days) for clinical recovery as per clinical recovery criteria. <br/ ><br>b) Number of patients showing â??clinical <br/ ><br>recoveryâ?? <br/ ><br>Timepoint: a) at baseline, 8th day, 14th day, 21st day (if required) showing â??clinical <br/ ><br>recoveryâ?? <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Percentage of patients with negative <br/ ><br>SARS-CoV-2 on nasal or throat swab in a 2 days continuous RT-PCR test. <br/ ><br>2.Improvement in selected laboratory <br/ ><br>Parameters: CBC, RBS, ESR, Hs-CRP, LDH,S.Ferritin, IL-6, LFT and RFT. <br/ ><br>3.No of cases Reporting any ADR/AE <br/ ><br>4. Number of participants referred with onset of complications. <br/ ><br>Timepoint: Baseline- <br/ ><br>8 days <br/ ><br>15 days <br/ ><br>