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CTRI Number  CTRI/2020/05/025335 [Registered on: 24/05/2020] Trial Registered Prospectively
Last Modified On: 25/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Trial 
Public Title of Study   Efficacy of AYUSH-64 (a polyherbal formulation) in COVID - 19 Cases  
Scientific Title of Study   A Pilot Study To Assess The Efficacy Of AYUSH - 64 In COVID - 19 Cases  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr N R Singh 
Designation  Professor and HOD- Kayachikitsa, Additional Director Academics 
Affiliation  Chaudhary Bahm Prakash Ayurved Charak Sansthan, New Delhi 
Address  CBPACS, Khera Dabar, Najafgarh New Delhi 110073
Additional Director office, room no G-31, CBPACS, Khera Dabar, New Delhi 110073
South West
DELHI
110073
India 
Phone  9560659728  
Fax    
Email  addl.director.academics@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr N R Singh 
Designation  Professor and HOD- Kayachikitsa, Additional Director Academics 
Affiliation  Chaudhary Bahm Prakash Ayurved Charak Sansthan, New Delhi 
Address  CBPACS, Khera Dabar, Najafgarh New Delhi 110073
Additional Director office, room no G-31, CBPACS, Khera Dabar, New Delhi 110073
South West
DELHI
110073
India 
Phone  9560659728  
Fax    
Email  addl.director.academics@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr N R Singh 
Designation  Professor and HOD- Kayachikitsa, Additional Director Academics 
Affiliation  Chaudhary Bahm Prakash Ayurved Charak Sansthan, New Delhi 
Address  CBPACS, Khera Dabar, Najafgarh New Delhi 110073
Additional Director office, room no G-31, CBPACS, Khera Dabar, New Delhi 110073
South West
DELHI
110073
India 
Phone  9560659728  
Fax    
Email  addl.director.academics@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences (C.C.R.A.S.), New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences CCRAS 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan 61-65, Institutional Area, Opposite D-Block, Janakpuri, New Delhi-110058  
Type of Sponsor  Research institution 
 
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 Vidula Gujjarwar  Ch. Brahm Prakash Ayurved Charak Sansthan, New Delhi  CBPACS,director office, Khera Dabar, Najafgarh New Delhi 110073
South West
DELHI 
9990174348

cbpayurved@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-CBPACS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayush-64, a polyherbal formulation.   The composition of AYUSH 64 includes aqueous extract of Saptaparna (Alstoniascholaris R. Br.) Katuki (Picrorhizakurroa Royle ex. Benth), Kiratatikta (SwertiaChirataPexbex. Karst) and powder of Kuberaksha (Caesalpinia crista Linn.) in the ratio of 1:1:1:2.Dose:- 2 Tablets (500 mg) thrice daily (2-2-2) Dosage form:- Tablet Route of Administration:- Oral Time of Administration:-after food Anupana:- Warm water Duration of therapy:- 14 days  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Mild to moderate cases registered in CHC CBPACS above 18 years of age, with COVID 2019 (Confirmed by RT-PCR)
Participants who can take medicines orally
Patients willing to provide signed informed consent
 
 
ExclusionCriteria 
Details  Cases of severe vomiting which would make oral administration of medicine difficult.
Cases of respiratory failure and requiring mechanical ventilation.
Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal.
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
Pregnant or lactating women
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’
 
Baseline
Day 8
Day 15 
 
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
8th after onset of symptoms depending on whichever of the two time points is first achieved
2. Improvement in selected laboratory parameters:,  
Baseline
Day 8
Day 15 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   31/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="5" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Brief Summary
Modification(s)  

 The experimental studies of AYUSH 64 has shown that it was safe and non-toxic in the dose of 500 mg/kg of body weight for 12 weeks. It is found to be effective in fevers of unknown etiology, filarial lymphangitis and derangement of liver function besides its anti-malarial activity.Taking leads from the clinical experiences of physicians who had successfully used AYUSH 64, for management of Influenza like Illness (ILI), a pilot study was conducted by  CCRAS, which concluded recently and is under the process of publication. This study was done in 34 cases of flu like illness, wherein Ayush 64 helped to recover from ILI symptoms with reduced frequency of usage of acetaminophen and antihistaminic..This lead to the idea of repurposing AYUSH 64 for use in the management of COVID positive cases. 

 
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