A clinical study of Ayurvedic formulations in the treatment of Mild to Moderate COVID-19 patients

INTERVENTION: Intervention1: i)AYUSH‐64 ii)Yashtimadhu iii)Sanshamani Vati Plus: i)AYUSH‐64, 500 mg tablet, 2 tablets bid, ii)Yashtimadhu 300 mg tablet, 2 tablets bid iii)Sanshamani Vati Plus,Each tablet to contain 300 mg Guduchi plus 75 mg Pippali, 2 tablets bid Each of these 3 Ayurvedic formulations will be assessed in 3 separate drug trial studies with a randomized two arm active controlled design using common protocol and methods Control Intervention1: Standard Care as per the Ministry of Health and family welfare guidelines for COVID19 and updated.: There is no specific therapy for COVID‐19. All patients will be treated under strict supervision of a qualified physician. Triage will be performed in all patients on initial diagnosis to assess severity and repeated as per clinical judgement. Patients with moderate disease will need to be treated as inpatients. Taking preventive measures to avoid spread of infection from the patient is essential including PPE and suitable masks. However symptomatic treatment will be given in Mild and Moderate cases to treat fever and cough. Empiric antimicrobials will be used to treat all likely pathogens causing uncomplicated pneumonia and SARI. Uncomplicated cases with mild hypoxia may need supplemental oxygen. Hydroxychloroquine and macrolide maybe considered as an off label agent in patients with severe progressive disease. Steroids are not recommended for use in mild and moderate disease. Patients with severe disease and requiring intensive care will be withdrawn from the study and continued management as per the guidelines CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery (see criteria below)] ; b) Proportion of patients showing clinical recoveryâ?? ; Timepoint: Baseline, Daily assessment during symptomatic phase or hospitalization phase till complete recovery, WEEK 4, week 8, and study completion week 12 SECONDARY OUTCOME: 1) Rate of patients with negative SARSCoV2 on nasal or throat swab RTPCR test ; 2) Timelines ‐ COVID‐19 symptoms onset and their elevation ; 3) Proportion of patients developing a serious complication that warrants withdrawal ; 4) Improvement in selected laboratory parameters ; 6) Serological Antibody assay ; 7) Radiological Improvement on digital chest Xray ; 8) Drug related side effects and toxicity, and tolerability ; 9) Health status WHO QOL bref, health related behavior fitness questionnaire. ; Timepoint: Baseline, Daily assessment during symptomatic phase or hospitalization phase till complete recovery, WEEK 4, week 8, and study completion week 12 INCLUSION CRITERIA: i.Typical clinical presentation of acute onset febrile illness with cough and a RT_PCR based laboratory confirmation test for COVID‐19 ii. Patients with either sex, 20 to 69 years age iii. Patients with mild to moderate patients iv. All patients must agree not to share medication v. Patients willing to participate and sign an informed consent