Study of use of Ayurveda Intervention (Ayush-64) in COVID 19

Phase 2

Not yet recruiting

Brief Summary: COVID -19 has emerged as the latest pandemic affecting millions of the people world over. Many interventions are being tried to prevent and treat the same. Central Council for Research in Ayurvedic Sciences has developed a poly-herbal drug â€œAYUSH 64â€ which is considered to be effective in diseases like malaria, pyrexia of unknown origin, filariasis etc. This drug was found to be beneficial in influenza like illness and found to be safe in previous studies. This study was designed to explore its efficacy and safety of â€œAYUSH 64â€in COVID -19 patients having mild disease.

In this trial, we are going to enroll 30 confirmed COVID-19 patients having very mild disease in intervention and control group each. Intervention group will be given 2 capsules/tablets (500 mg each) every 8 hourly while control group will be on standard treatment as per the institution policy. The primary endpoint for this trial is â€œtime to negative conversion of COVID 19â€ based on the report of RTPCR. Various secondary endpoints like duration of fever and respiratory symptoms, hematological parameters, adverse events, no. of patients referred, number cases requires oxygen therapy and no. of cases progressed to multiorgan failure will also be compared between intervention and control groups.

Recruitment & Eligibility

Inclusion Criteria

1.Patients of 18-60 yrs of age, clinically diagnosed with corona virus disease 2019 by RTPCR test coming under stage I- mild (Early infection) 2.Participants who can take medicines orally.
3.Patients willing to provide signed informed consent.

Exclusion Criteria

Primary Outcome Measures

Name	Time	Method
Clinical cure rate: Time to negative conversion of COVID19.	Time to event

Secondary Outcome Measures

Name	Time	Method
Number of cases that required invasive or non-invasive oxygen therapy during the intervention.	Baseline to one month
Duration of fever and each of the respiratory symptoms	Baseline to one month
No of cases Reporting any ADR/AE	Baseline to one month
Improvement in hematological and laboratory parameters (CBC, LFT, RFT, RBS, ESR, Hs-CRP, LDH, CXR, ABG, S. Ferritin, D-dimer, ECG)	Baseline to one month
Number of patients referred	Baseline to one month
Number of cases that progressed to multi-organ failure while under clinical trial	Baseline to one month

Locations (1): All India Institute of Medical Sciences, Jodhpur
🇮🇳
Jodhpur, RAJASTHAN, India
All India Institute of Medical Sciences, Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
Dr Pankaj Bhardwaj
Principal investigator
8003996903
pankajbhardwajdr@gmail.com