Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Zandu Chyavanprash: Zandu Chyavanprash include Bilva, Agnimantha, Syonaka, Patala, Gambhari, Shalaprani, Prishniparni , Brihati, Kantakari, Gokshura, Bala, Mudgaparni, Mashaparni, Kark
Sponsors
Emami Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with mild to moderate symptoms [as per US-CDC classification of COVID-19 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. Ready to provide written informed consent for participation in the study 5. 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 with known history of Diabetes Mellitus 2. Patients having difficulty in swallowing oral medications. 3. AYUSH system-based contraindications 4. 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 (Greater than or equal to 30 breaths per min) (ii) Oxygen saturation at rest less than or equal to 93 percent (peripheral digital oxymeter) 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. 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 COVID-19 (Day of randomization to the day of clinical recovery and from the day of first noticed symptoms) 2. Comparative assessment of post-clinical recovery (signs, symptoms, lab parameters) over a period of 8 weeks between the two groups. Timepoint: Screening Visit (Day -3 to day 0) Baseline Visit (Day 0), Evaluation during hospitalization, Day 7, Discharge visit, Day 14, Day 28, Day 42 and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean time (days) required for testing negative for SARS-CoV-2 2. Change in duration of fever and other respiratory symptoms and WHO Ordinal scale 3. Changes in disease progression and requirement of Oxygen, ICU and Ventilator Support 4. Changes in percent mortality, post clinical recovery, lab parameters, rescue medication, health status on WHO QOL BREF 5. Global assessment of overall change as per the investigator and the subject 6. AE, SAETimepoint: Screening Visit (Day -3 to day 0) Baseline Visit (Day 0), Evaluation during hospitalization, Day 7, Discharge visit, Day 14, Day 28, Day 42 and Day 56 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed