FULL DETAILS (Read-only)

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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 

 

Close