Clinical study to evaluate efficacy and safety of GanjhuVir syrup and tablet in Covid-19 positive patients.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/07/026463
- Lead Sponsor
- Radhika Ayurveda Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female volunteers aged between 18 to 65 years both inclusive.
2. Ready to give informed volunteer consent.
3. Respiratory Syndrome caused by Corona virus infection confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests.
4. Patient who require hospitalization.
5. Diabetic patients with sugar levels in normal limits.
6. Females must be using an effective contraception method or other form of birth control prior to and during the study and use will continue till EOS.
7. Males will ensure that their female partners of childbearing potential will utilize an effective contraceptive method or other form of birth control to avoid pregnancy.
1.Previously treated with antiviral therapy, systemic steroids or immunosuppressant within 2 weeks prior to study Day1.
2. Participation in any other clinical trial of an experimental treatment for Covid-19 or any other clinical trial of different indication.
3. Hospitalization in ICU.
4. Evidence of multiorgan failure, suspected latent tuberculosis infection
5. Requiring mechanical ventilation at screening.
6. Any known severe allergic/ hypersensitivity to GanjhuVir syrup or tablet.
7. Patients with chronic kidney disease, cardiac anomaly, receiving cancer therapy, HIV positive or Hepatitis positive.
8. Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or lactating.
9. Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in thisstudy.
10. Participation in another trial with an investigational drug within 1 month prior to this trial.
11. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method