Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Guduchi Ghan Vati: Dose: 2 capsule/tablet (250 mg each)
Frequency: Twice a day after food.
Route: Oral
Anupana: Water
Duration: 10 days
Control Intervention1: Hydroxychloroquine (HCQ):
Sponsors
Directorate of AYUSH Government of Madhya Pradesh
Eligibility
Inclusion criteria
Inclusion criteria: Mild to moderate cases registered in the Hospital, above 18 years of age, with COVID 2019 (Confirmed by RT-PCR) quarantined at identified hospital set up. Participants who can take medicines orally. Patients willing to provide signed informed consent.
Exclusion criteria
Exclusion criteria: Cases of severe vomiting which would make oral administration of medicine difficult. Cases of respiratory failure and requiring mechanical ventilation. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal. Patients with COVID 19 in critical condition or ARDS or NIAD 8 â??point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation Pregnant or lactating women Any other condition, which as per the investigator would jeopardize the outcome of the trial. Withdrawal Criteria: a) The participant may be withdrawn from the trial if there is Any major ailment which necessitating the institution of new modalities of treatment. OR Non-compliance of the treatment regimen (minimum 80% compliance is essential to continue in the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure rate: Time to negative conversion of severe acute respiratory syndrome corona-virus 2. (From the days of randomization)Timepoint: 5th day, 10th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of fever and each of the respiratory symptoms. 2. Improvement in hematological and laboratory parameters (CBC, LFT, RFT, RBS, ESR, Hs-CRP, LDH, CXR, ABG, S. Ferritin, D-dimer, ECG). 3. No of cases Reporting any ADR/AE. 4. Number of patients referred. 5. Number of cases that required invasive or non-invasive oxygen therapy during the intervention. 6. Number of cases that progressed to multi-organ failure while under clinical trial.Timepoint: 7th day, 10th day;Criteria of â??Clinical Recovery: i. Normal body temperature ii. Absence of cough or mild cough (infrequent, short episodic, non-wheezy, relieved by minimal or no medication, not interfering with routine speech and not related to lying in bed, mild sore throat or nasal congestion) iii. Absence of breathlessness on routine daily self-care chore or respiratory rate 30 breaths per minute without supplemental oxygen iv. Absence of any other symptom/sign attributed to COVID-19 illnessTimepoint: 7th day, 10th day | — |
Countries
India
Contacts
Public ContactDr Nitin Ujjaliya
Pt. Khushilal Sharma Government Ayurveda College and Institute Bhopal
Outcome results
None listed