CTRI Number |
CTRI/2020/10/028570 [Registered on: 22/10/2020] Trial Registered Prospectively |
Last Modified On: |
21/10/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
To study the effect of Vyaghradi Kashay tablet on COVID-19 patients |
Scientific Title of Study
|
An interventional, single arm study to observe and assess the effectiveness of “Vyaghradi Kashaya Tab†in preventing the progression of severity in asymptomatic, mild to moderate 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 Manoj Shamkuwar |
Designation |
Associate Professor and HOD Dept of Panchakarma |
Affiliation |
A and U Tibbia College and Hospital Govt of NCT of Delhi |
Address |
Department of Panchakarma
A and U Tibbia College and Hospital
Karol Bagh
New Delhi DELHI 110005 India |
Phone |
|
Fax |
|
Email |
manoj_1873@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manoj Shamkuwar |
Designation |
Associate Professor and HOD Dept of Panchakarma |
Affiliation |
A and U Tibbia College and Hospital Govt of NCT of Delhi |
Address |
Department of Panchakarma
A and U Tibbia College and Hospital
Karol Bagh
New Delhi DELHI 110005 India |
Phone |
|
Fax |
|
Email |
manoj_1873@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Nitin Jindal |
Designation |
Assistant Professor |
Affiliation |
A and U Tibbia College and Hospital |
Address |
Department of Panchakarma
A and U Tibbia College and Hospital
Karol Bagh
New Delhi DELHI 110005 India |
Phone |
|
Fax |
|
Email |
nitjin2005@gmail.com |
|
Source of Monetary or Material Support
|
A and U TIbbia College and Hospital
Govt of NCT of Delhi |
|
Primary Sponsor
|
Name |
Ministry of AYUSH Govt of India |
Address |
GPO Complex, AYUSH BHAWAN, B Block, INA Colony, New Delhi, Delhi 110023 |
Type of Sponsor |
Other [Ministry of AYUSH Govt of India] |
|
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 Nitin Jindal |
A and U Tibbia College and Hospital Govt of NCT of Delhi |
COVID Ward - Maternity Block
Ajmalkhan Road
Karol Bagh New Delhi DELHI |
9354925045
nitjin2005@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ayurvedic and Unani College and Hospital, Govt of NCT of Delhi |
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 |
Comparator Agent |
Not applicable |
Not applicable |
Intervention |
Vyaghradi Kashay Tablet |
Drug- Vyaghradi Kashay Tablet
Dose : One tab(500mg)three times a day with luke warm water
Route -Oral
Duration - 7 days (Initially). If RTPCR Not negative in 7 days it will continue up to 14 days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
People who have been tested positive to be infected with SARS-CoV2 virus and presenting with no symptoms or with mild to moderate symptoms.
All the patients of age group 18-65 yrs
All those who are willing to give written consent for participation in the study
|
|
ExclusionCriteria |
Details |
COVID patients with symptoms classified as severe or critical.
Persons with severe primary respiratory disease or other pneumonia
Pregnant and lactating women
Persons with serious complications of diseases such as cancer, heart disease, stroke, disabilities, mental illnesses, etc., and who are considered to be excluded from the study as evaluated by the investigators
COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical trials.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Time taken to be tested negative for SARS-CoV2 in RT-PCR.
To Assess the effect of drug in preventing the progression of severity of symptoms. |
a)RT PCR 7th and 14th Day
b)Assessment of clinical recovery at baseline, Daily 7-14 days
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Secondary outcome-
To assess the effect of Vyaghradi Kwath Tab on blood parameters specific to Covid-19.
|
08-15 days |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 2/ Phase 3 |
Date of First Enrollment (India)
|
05/11/2020 |
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="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
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 (COVID-19) is a pandemic started from Wuhan City of China in December 2019, with the case of Pneumonia with unknown cause later on in the mid of January 2020 it was declared as an emergency. There are Numerous studies have been published, establishing evidence and opinion-based guides current COVID-19 pandemic, which has taken the world by storm. The sudden outbreak of COVID-19 making society of the people realizes the threat of communicable diseases to human being. A whole-of-society approach is needed to tackle 21st century epidemics so that all the different type of epidemic disease is to be taken into consideration. Genetics and biological factors, ecology and the physical environment; are also affecting causes. This increasing convergence of many factors that requires multi-disciplinary, multi-sectoral and multi-faceted approaches. Ayurved can be helpful in pandemic disease like COVID-19. In COVID patients Cough and sputum, Chest tightness, Difficulty breathing, Fever, Fatigue, Nasal congestion, runny nose, Sick and vomiting are the common symptoms. Vyaghradi Kashaya is indicated in Vatshleshmak jwara having the symptoms like cough, running nose, breathlessness. Therefore, the proposed study is designed to search out the effectiveness of Vaghradi Kashay in asymptomatic and mild to moderate cases of COVID-19. The composition of the drug is Kantakari (Solanum xanthocarpum), Sunthi (Zingiber officinale), Amruta (Tinospora cordifolia), Pippali (Piper longum).These drugs have antiviral, antibacterial, antioxidant and immunomodulator property. |