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CTRI Number  CTRI/2020/08/027346 [Registered on: 24/08/2020] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To assess the clinical efficacy of Ayurvedic interventions in managing asymptomatic to mild cases of COVID-19 
Scientific Title of Study   A prospective randomized controlled clinical trial to evaluate the efficacy and safety of Ayurvedic interventions in the management of COVID-19(Asymptomatic to moderate cases) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shikha Chaudhary 
Designation  Assistant professor 
Affiliation  shri dhanwantry ayurvedic college and hospital 
Address  Department of Research, room no 110, shri dhanwantry ayurvedic college and hospital 77 chandi path sector 46 B Chandigarh

Chandigarh
CHANDIGARH
160047
India 
Phone  9205109463  
Fax    
Email  drshikha08@icloud.com  
 
Details of Contact Person
Scientific Query
 
Name  Shikha Chaudhary 
Designation  Assistant professor 
Affiliation  shri dhanwantry ayurvedic college and hospital 
Address  Department of Research, room no 110 shri dhanwantry ayurvedic college and hospital 77 chandi path sector 46 B Chandigar

Chandigarh
CHANDIGARH
160047
India 
Phone  9205109463  
Fax    
Email  drshikha08@icloud.com  
 
Details of Contact Person
Public Query
 
Name  Shikha Chaudhary 
Designation  Assistant professor 
Affiliation  shri dhanwantry ayurvedic college and hospital 
Address  Department of Research, room no 110, shri dhanwantry ayurvedic college and hospital 77 chandi path sector 46 B Chandigarh

Chandigarh
CHANDIGARH
160047
India 
Phone  9205109463  
Fax    
Email  drshikha08@icloud.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Shri Dhanwantry ayurevdic college and hospital 
Address  77 chandi path sector 46 B Chandigarh 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rijin Mohan  Shri Dhanwantry Ayurvedic college and hospital  Department of research, room number 110, Shri Dhanwantry Ayurvedic college and hospital, 77 Chandi path sector 46 B , Chandigarh,
Chandigarh
CHANDIGARH 
9496463399

drrijinm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayush-64, Agasthya Haritaki, Anu taila Nasal drops  AYUSH-64 500 mg Tablets Oral Twice a day 2 hrs after food Lukewarm water for 10 days Agasthya Haritaki Avleha 5 gm Oral Twice a day 2 hrs before food Lukewarm water for 10 days Anu taila 2 drops Oil Nasal instillation Twice a day for 10 days 
Intervention  Broncho-T Granules  50 ml Decoction Oral Thrice a day 1 hrs before food Lukewarm water for 10 days 
Comparator Agent  Standard conventional treatment as per ICMR guidelines  Symptomatic care 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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.
2. Participants who can take medicines orally
3. Patients willing to provide signed informed consent 
 
ExclusionCriteria 
Details  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 patient´s best interest.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Mean time for clinical recovery  1. 5th and 10th day 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/08/2020 
Date of Study Completion (India) 08/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   COVID-19 has emerged as the latest pandemic which is affecting human health and economy across the worldThe first case of the 2019–20 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 worldwideDrug 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 ‘AYUSH 64’ 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.
  
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