Evaluation of efficacy of Fixed Ayurvedic Regimen of Giloy Ki Ghan Vati,Tulsi Tablets,Kalmegh Tablets and Dabur Chyawanprash in COVID-19

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: 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 28 days Intervention4: Dabur chyawanprash: 1 Teaspoonful (Approx 10‐12 grams) two times a day for 28 days Control Intervention1: Standard care: Conventional Treatment as advised / prescribed by concerned health authorities CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 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 OUTCOME: 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 Xâ??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 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.
Epistemonikos ID: 864949dd778357a38e26f0cf1f854b8f7fcc46f6
First added on: Nov 07, 2020