| CTRI Number |
CTRI/2020/05/025338 [Registered on: 24/05/2020] Trial Registered Prospectively |
| Last Modified On: |
30/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
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
Modification(s)
|
| 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
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Ayush 64 |
Dose: 2 Tablets(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: 7 or 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.Asymptomatic, Mild to moderate cases registered in A & U, Tibia hospital above 18-60 years of age, with COVID 2019 (Confirmed by RT-PCR or Rapid Antigen Test) quarantined at identified hospital set up.
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
Modification(s)
|
| Outcome |
TimePoints |
1.Negative status of SARS-CoV-2 on nasal or throat swab after 07 days or 14 days of intervention in a 2 day continuous real time RT-PCR test.
2. Changes in liver enzymes, Renal functions |
1.Negative status of SARS-CoV-2 on nasal or throat swab after 07 days or 14 days of intervention in a 2 day continuous real time RT-PCR test.
[Time frame: 8th day or 15th day]
2. Changes in liver enzymes, Renal functions [Time frame: 8th day or 15th day] |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Mean time (days) for clinical recovery as per clinical recovery criteria defined.
2.Number of symptomatic patients showing ‘clinical recovery’.
Improvement in selected laboratory parameters:, differential and total leukocyte counts, acute phase reactants, serum IL-6, Serological Protective Antibody Assay (IgE ,IgM and IgG). |
1.Mean time (days) for clinical recovery as per clinical recovery criteria defined.
[time frame:7th day,14th day if RTPCR positive-on 8th or 9th Day]
Time frame: 8th day or 15th day
2.Time frame: 8th day (after intervention of 7 days) or 15th day( in case intervention for 14 days). |
|
|
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 |
