To assess the clinical efficacy of Ayurvedic interventions in managing asymptomatic to mild cases of COVID-19

Phase 2/3

Completed

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2020/08/027346

Lead Sponsor: Shri Dhanwantry ayurevdic college and hospital

Brief Summary: COVID-19 has emerged as the latest pandemic which is affecting human health and economy across the world. The first case of the 2019â€“20 coronavirus pandemic in the Indian state of Maharashtra was confirmed on 9thMarch 2020.

Coronaviruses (CoVs) belong to the family Coronaviridae and are enveloped, single-stranded, positive-sense RNA viruses.The SARS-CoV-2 belongs to the beta CoV genus which also includes the SARS-CoV-1 and the MERS-CoV. The lack of approved effective drug therapeutic protocols for CoVs would be a challenge for the treatment of the newly emerged COVID-19 infections worldwide. Drug repurposing, which is defined as identifying alternative uses for approved or investigational drugs outside their defined indication, could be a possible way to overcome the time limitation of research and development needed to design a therapeutic drug to combat the pathogen. The drug repurposing or repositioning approach thus can facilitate prompt clinical decisions at lower costs than de novo drug development. Though drug repurposing is sometimes based on chance observations, target-based repurposing of drugs depends on prior understanding of the precise molecular or cellular element that is recognized by the proposed drug.

Ayurveda and traditional systems of Medicine in India have been treating diseases of infectious and non-infectious origin equally with expansive success rates, treating the patients through an individualized person to person approach depending upon the presentation of clinical symptoms in each. Central Council for

Research in Ayurvedic Sciences, apex body for research and development in Ayurveda in India under Ministry of AYUSH has developed a poly-herbal drug â€˜AYUSH 64â€™ through extensive pharmacological, toxicological and clinical studies.

Taking leads from the clinical experiences of physicians who had successfully used mentioned ayurvedic interventions without any noticeable adverse events in Influenza like illness. This lead to the idea of repurposing these interventions for use in the management of Covid-19 positive cases which also present with Influenza like symptoms owing to affliction of respiratory tract.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Asymptomatic to moderate cases registered in the Hospital, above 18 years of age of either gender, with COVID 2019 (Confirmed by Antigen test/ RT-PCR) quarantined at our hospital.
Participants who can take medicines orally 3.
Patients willing to provide signed informed consent.

Exclusion Criteria

1.Patients suffering from severe COVID-19 Disease as judged by a physician 2.Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, 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 3.Patients who are likely to worsen or planed ICU admission or ventilator support due to any reason 4.Pregnancy and lactation 5.Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19 6.Participation in any other clinical trial of an experimental agent treatment for COVID-19 7.
Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind.
8.Physician decision that involvement in the study is not in the patientÂ´s best interest.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Mean time for clinical recovery	1.5th and 10th day

Secondary Outcome Measures

Name	Time	Method
Changes in Laboratory and Radiological parameters (RT-PCR, CBC, ESR, LFT, RFT, BS, CRP, D-dimer, Lipid profile, HRCT chest).	1st 5th and 10th day

Trial Locations

Locations (1): Shri Dhanwantry Ayurvedic college and hospital
🇮🇳
Chandigarh, CHANDIGARH, India
Shri Dhanwantry Ayurvedic college and hospital
🇮🇳Chandigarh, CHANDIGARH, India
Dr Rijin Mohan
Principal investigator
9496463399
drrijinm@gmail.com