CTRI Number |
CTRI/2020/05/025338 [Registered on: 24/05/2020] Trial Registered Prospectively |
Last Modified On: |
09/10/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Trial |
Public Title of Study
|
Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush -64) in the management of COVID-19 infection (Asymptomatic &Mild to Moderate symptoms |
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush -64) in the management of COVID-19 infection (Asymptomatic &Mild to Moderate symptoms)- An open label single arm prospective clinical trial |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
NA |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Dr Manoj Shamkuwar |
Address |
Department of Panchakarma
A and U Tibbia College and Hospital
Govt. of NCT of Delhi
Karol Bagh,
New Delhi
Central DELHI 110005 India |
Phone |
9354925019 |
Fax |
|
Email |
manoj_1873@yahoo.co.in |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
Dr BabitaYadav |
Address |
Room No 119 A
Central Council for Research in Ayurvedic Sciences,
D Block Janakpuri, New Delhi
South West DELHI 110058 India |
Phone |
9910171143 |
Fax |
|
Email |
drbabitayadav@gmail.com |
|
Details Contact Person Public Query
Modification(s)
|
Name |
Dr Shivshankar Rajput |
Address |
IPD Building First Floor
Central Ayurved Research Institute for cardiovascular Diseases, Road No. 66 Punjabi bagh west , New Delhi
West DELHI 110026 India |
Phone |
8460819669 |
Fax |
|
Email |
shivshankerdr@gmail.com |
|
Source of Monetary or Material Support
|
Central Council For Research in Ayurvedic Sciences
Ministry of AYUSH
Govt of India |
|
Primary Sponsor
|
Name |
Central Council For Research in Ayurvedic Sciences |
Address |
J.L.N.B.C.A.H. Anusandhan Bhawan,no. 61-65, Institutional area,
opposite D Block, Janakpuri |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Manoj Shamkuwar |
A and U Tibbia College and Hospital |
COVID 19 Ward
Maternity and Medicine Block
Ajmalkhan Road
Karol Bagh
New Delhi Central |
9423039441
manoj_1873@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
A and U Tibbia College IEC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
Coronavirus as the cause of diseases classified elsewhere |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Ayush 64 |
Dose: 2 capsules (500 mg each) thrice daily (2-2-2)
Dosage form: Tablets
Route of Administration: Oral
Time of Administration: Thrice a day after food
Anupana: Warm Water
Duration of therapy: 14 days
|
Comparator Agent |
Not applicable |
Not applicable |
|
Inclusion Criteria
Modification(s)
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Mild to moderate cases registered in Ayurved and Unani Tibbia College and Hospital Designated as COVID Health Center above the age of 18 years, with COVID 2019 (Confirmed by RT-PCR) quarantined at identified hospital setup.
2.Participants who can take medicines orally
3.Patients willing to provide signed informed consent |
|
ExclusionCriteria |
Details |
1.Cases of severe vomiting which would make oral administration of medicine difficult.
2.Cases of respiratory failure and requiring mechanical ventilation.
3.Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal.
4.Patients with COVID 19 in critical condition or ARDS or NIAD 8 –point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation
5.Pregnant or lactating women
6.Any other condition, which as per the investigator would jeopardize the outcome of the trial. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
a) Mean time (days) for clinical recovery as per clinical recovery criteria defined below.
b) Number of patients showing ‘clinical recovery’.
|
a) Mean time (days) for clinical recovery as per clinical recovery criteria defined below. [Time frame: Daily]
b) Number of patients showing ‘clinical recovery’. [Time frame: Daily] |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Percentage of patients with negative SARS-CoV-2 on nasal or throat swab in a 2 day continuous real time RT-PCR test beginning from ‘first day of clinical recovery’ or day after onset of symptoms depending on whichever of the two time points is first achieved
2. Improvement in selected laboratory parameters:, differential and total leukocyte counts, , acute phase reactants, serum IL-6, Serological Protective Antibody Assay (IgE ,IgM and IgG) |
Time frame: 8th day or 15th day |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
02/06/2020 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="0" Months="3" Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Under Process |
Brief Summary
Modification(s)
|
In this Clinical trial, among 40 participants, 36 have completed the trial, and 04 patients dropped out. Out of the dropout, SAE was observed in 2 participants. Among 36 those completed the study, 25 participants got RT-PCR negative after seven days, and the rest 11 got RT-PCR negative after 14 days. No adverse changes were found in liver enzymes and renal functions. Ayush 64 found useful to reduce the symptoms of Jwara concerning COVID-19 and further progression of the disease |