| CTRI Number |
CTRI/2020/07/026468 [Registered on: 10/07/2020] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Drug Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients
|
|
Scientific Title of Study
|
A Randomized, Open Label, Parallel Efficacy, Active Control, Multi- Centre Exploratory Drug Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation III [Yashtimadhu] as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| COVID 19/AYUSH-ICMR 2020/Adjunct Protocol-AF-III |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Pranjal Ausekar |
| Designation |
Head-Operations & Project Management |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office 305 309, Level-3, West Wing, Nyati Unitree, Yerwada-411006, Maharashtra, India
Office 305 309, Level-3, West Wing, Nyati Unitree, Yerwada-411006, Maharashtra, India
Pune
MAHARASHTRA
411001
India |
| Phone |
7276283528 |
| Fax |
- |
| Email |
pranjal@ardent-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip Mondhe |
| Designation |
Senior Principal Scientist & Head Cancer Pharmacology Division & IIIM-Dispensary |
| Affiliation |
Indian Institute of Integrative Medicine (Council of Scientific & Industrial Research) |
| Address |
Research Department, Canal Road,
Jammu 180001 (J & K)
Jammu 180001 (J & K)
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
|
| Fax |
|
| Email |
dmmondhe@iiim.ac.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Chandu Devanpally |
| Designation |
Founder & Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office 305 309, Level-3, West Wing, Nyati Unitree, Yerwada-411006, Maharashtra, India
Office 305 309, Level-3, West Wing, Nyati Unitree, Yerwada-411006, Maharashtra, India
Pune
MAHARASHTRA
411001
India |
| Phone |
9545817447 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
|
Source of Monetary or Material Support
|
| AYUSH CSIR,
research Department, Canal Road, Jammu. |
|
|
Primary Sponsor
|
| Name |
AYUSHCSIR |
| Address |
Canal Road, Jammu 180001 (J & K) |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil Kumar |
AVBRH DMIMS |
Department of Medicine, Acharya Vinoba Bhave Rural Hospital, Datta meghe institute of Medical Sciences, Sawangi, Wardha
Wardha
MAHARASHTRA |
9850393787
-
sunilkumarmed@gmail.com |
| Dr Jaya Chakravarty |
Banaras Hindu University |
Department of General Medicine
Institute of Medical Sciences, Banaras Hindu University, Varanasi- 221005
Varanasi
UTTAR PRADESH |
9453003785
-
tapadar@gmail.com |
| Dr Atul Rajkondawar |
Meditrina Institute of Medical Sciences |
278, Central Bazar Road, Ramdaspeth, Nagpur
Nagpur
MAHARASHTRA |
9373215775
atul.rajkondawar@gmail.com |
| Dr Umar Quadari |
MGM Medical College and Hospital |
Department of medicine,MGM Campus, N-6, CIDCO, Aurangabad -431003
Aurangabad
MAHARASHTRA |
7558404702
-
umarazmed@gmail.com |
| Dr Aparna Kodre |
Noble Hospital PVt. Ltd. |
153, Magarpatta, Hadapsar-411013
Pune
MAHARASHTRA |
9850136436
draparnakodre@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Meditrina Institute Ethics Committee |
Approved |
| MGM Ethics Committee for Research on Human Subjects |
Approved |
| Noble Hospital Institutional Ethics Committee |
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 |
Formulation 3 and SOC |
Yashtimadhu, 300 mg, 2 tablets ,2 times a day for 12 weeks along with standard of care. |
| Comparator Agent |
Only Standard of Care Treatment |
As per Hospital protocol |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i) Typical clinical presentation of acute onset febrile illness with cough and a RT_PCR based laboratory confirmation test for COVID-19. The patients may have other symptoms such as fever (patients with episodes of fever up to 48 hrs. and constant fever reading will be considered), myalgia, headache, diarrhoea and tastelessness suggestive of COVID-19.
ii. Patients with mild to –moderate diseasePatients must agree not to share medication
iii. Patients willing to participate and sign an informed consent |
|
| ExclusionCriteria |
| Details |
i. Patients suffering from severe COVID-19 Disease as judged by a physician
ii. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study
iii. History of immunosuppression: solid organ or bone marrow transplant, use of immunosuppressive antimetabolic and biologic agents, intrinsic immunodeficiencies, HIV infection.
iv. Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
v. Atleast one fever episode every 24 hours for > 72h
vi. Patients on parenteral nutrition
vii. Patients with known sensitivity or contraindication to any of the ingredients of study medication
viii. History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.)
ix. Patients who are likely to worsen or planned ICU admission or ventilator support due to any reason
x. Pregnancy and lactation
xi. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19
xii. Participation in any other clinical trial of an experimental agent treatment for COVID-19
xiii. Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind.
xiv. Physician decision that involvement in the study is not in the patient´s best interest |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
Modification(s)
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery (see criteria below)]
b) Proportion of patients showing clinical recovery |
From baseline up to 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Rate of patients with negative SARS-CoV-2 on nasal or throat swab in a 2 day continuous real time RT-PCR test
2) Timelines (days counted from onset of illness)- normal body temperature, absence or minimal cough (see ‗clinical recovery‘ for the definition), absence of dyspnoea, onset of clinical pneumonia, pneumonia |
from baseline up to 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
18/09/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coronavirus
Disease-19 (COVID-19) pandemic has unleashed an unprecedented damage to life and
livelihood. Over four Million people have contracted the disease globally and
almost 2.7 lakh have died by the end of April
2020. There is no specific therapy
and the vaccine is likely to be ready
by early 2021 if not earlier. All
the global strategies are focussed on stringent measures to contain the virus and mitigate the
suffering of the people. India is under lockdown since early March 2020
and the situation though grim is fairly
stable. There is an upward trend in number of cases but the health care system is suitably meeting the challenge. Clinical research is a vital part of such epidemics. There is a dire need to find newer
more effective drugs or at least improve
the current standard of care.
India has a
rich tradition of Ayurveda since ancient times and several ‗Rasayana‘ drugs are
well known to enhance the immunity
status. Though COVID 19 is an acute
infectious disease with a predominant affliction for lungs and airways, the
clinical experience so far has shown
a rapidly progressive inflammation triggered by several exuberant immunological
events. Therefore, there may be a
potent role of immunity enhancing and or immunomodulators drugs in the medical management of COVID 19. It is against this perspective that the
Ministry of AYUSH and Council of
Scientific & Industrial Research (CSIR) have initiated an ambitious and
comprehensive research program to discover
Ayurveda formulations with proven value in the
chemoprophylaxis and treatment of COVID 19.This is a prospective, randomized, open label, blinded end point (PROBE), parallel efficacy, multicentric, two arm study to compare the efficacy of a combination of Standard of CareSOC) plus one of the selected individual Ayurveda herbal drug (Samshamani Vati Plus or AYUSH 64 or Yashtimadhu) to SOC (active control). The Ayurveda drug is being considered as an adjunctive or an add-on therapy and each of the three drugs will be evaluated in separate two arm trial with a common study design. The drug trials are ‗ ‘exploratory’ in design. The Study Flow diagram summarizes the study design and schedule of events |