CTRI Number |
CTRI/2020/05/025335 [Registered on: 24/05/2020] Trial Registered Prospectively |
Last Modified On: |
19/10/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
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
|
|
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
|
|
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, 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
Modification(s)
|
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.
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)
3.Changes in liver enzymes, Renal functions
4.No of cases Reporting any ADR/AE
5.Number of participants referred with onset of complications
|
Baseline
8th day
15th day |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="37" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
20/06/2020 |
Date of Study Completion (India) |
11/08/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
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. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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. So a single arm, open, prospective, non-controlled, interventional pilot study was conducted at Chaudhary Brham Prakash Ayurved Charak Sanstha (CBPACS), Khera Dabar, Najafgarh. A total of 64 patients of either sex above 18 years of age, confirmed cases of COVID 19 disease have been screened for taking 40 patient and 37 patients were enrolled in the study. The enrolled patients were assessed at baseline, 8th day and 15th day after their enrolment in the study. Out of 37 patients, 4 were drop out and rest 33 completed the study. Out of the completed 33 patients, 18 patients became COVID negative on 8th day and 7 patients became COVID negative on 15th day. 8 patients were those, who were COVID positive after completion of the trial. |