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
|
|
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
|
|
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
|
|
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 world. The 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 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 ‘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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