Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Tulsi tablets: 1 Tablet two times a day for 28 days
Intervention2: Giloy ki Ghanvati: 1 Tablet two times a day for 28 days
Intervention3: Kalmegh Tablets: 1 Tablet two times a day for 2
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects between the age groups of 18 and 60 years 2. Clinical presentation with Laboratory (RT-PCR or Rapid antigen or any other test for COVID19 as per current guidelines) confirmed infection of COVID-19 3. Subjects having symptoms not more than 3 days 4. Patients with mild to moderate symptoms [as per US-CDC classification of COVID-19 (Ref: www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidancemanagement-patients.html) (Mild symptoms up to mild pneumonia) 5. Ready to provide written informed consent for participation in the study 6. Willing to follow COVID-19 (prevention and containment) related guidelines issued from time to time by Govt./ local health authority throughout the study period.
Exclusion criteria
Exclusion criteria: 1. Patients suffering from severe COVID-19 disease as judged by a physician and fulfilling at least two of the following three criteria (i) Respiratory distress at room ambience (�30 breaths per min) (ii) Oxygen saturation at rest �93% (peripheral digital oximeter) and requiring oxygen support for over one hour to normalize (iii) Any of the known COVID-19 complications and emergency procedures which may require shift/admission in intensive care unit such as respiratory failure, adult respiratory distress syndrome, requirement of oxygen support for over 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure. 2.Patients with known history of Diabetes Mellitus 3.Patients having difficulty in swallowing oral medications. 4.AYUSH system-based contraindications 5.Patients who have participated in other clinical trials within last 1 month; 6. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study 7. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment. 8.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening 9.Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. 10.Subjects taking steroid treatment and or any kind of immunosuppressive therapy prior to participation in the study 11. Allergies, known to be allergic to Investigational Products (Ayurvedic Formulations) 12. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean time (days) required for clinical recovery from COVID19 (Day of randomization to the day of clinical recovery and from the day of first noticed symptoms) (Criteria for clinical recovery as mentioned below) 2. Proportion of patients showing clinical recovery between the two groupsTimepoint: Baseline /Screening, Evaluation during hospitalization, At Discharge Visit, Post Discharge at 14 and 28 day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean time (days) for testing negative for SARS-CoV-2 from the day of randomization and from the day of first noticed symptoms. 2. Assessment of/on-Fever & respiratory symptoms,WHO Ordinal scale,Requirement of Oxygen, ICU admission,Ventilator Support No.of days of hospitalization,% mortality,Post-clinical recovery, Changes in lab safety parameters,chest Xââ?¬â??ray,Rescue medication,WHO QOL BRIEF,Global assessment,AE/SAETimepoint: Baseline /Screening, Evaluation during hospitalization, At Discharge Visit, Post Discharge at 14 and 28 day | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Dabur India limited
Outcome results
None listed