CTRI Number |
CTRI/2020/05/025385 [Registered on: 27/05/2020] Trial Registered Prospectively |
Last Modified On: |
30/12/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Non-randomized, Multiple Arm Trial |
Public Title of Study
|
Research study to evaluate the impact of Selected Ayurvedic interventions in containment zone |
Scientific Title of Study
Modification(s)
|
A prospective non-randomized open label controlled interventional study on the effect of Guduchi Ghan Vati/ Sudarshan Ghan Vati as a prophylactic measure among Containment Zone population exposed to COVID 19" |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
Nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Prof KS Dhiman |
Address |
Central Council for Research in Ayurvedic sciences, Janakpuri, New Delhi 110058 Room Number 224, Jawaharlal Nehru Anusandhan Bhawan, Janakpuri South West DELHI 110058 India |
Phone |
011-28524457 |
Fax |
|
Email |
dg-ccras@nic.in |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
Vipin Sharma |
Address |
Central Council for Research in Ayurvedic sciences, Janakpuri, New Delhi 110058 Room Number 103, Jawaharlal Nehru Anusandhan Bhawan, Janakpuri. South West DELHI 110058 India |
Phone |
9899437195 |
Fax |
|
Email |
sharma.vipin@nic.in |
|
Details Contact Person Public Query
Modification(s)
|
Name |
Vipin Sharma |
Address |
Central Council for Research in Ayurvedic sciences, Janakpuri, New Delhi 110058 Room Number 103, Jawaharlal Nehru Anusandhan Bhawan, Janakpuri South West DELHI 110058 India |
Phone |
9899437195 |
Fax |
|
Email |
sharma.vipin@nic.in |
|
Source of Monetary or Material Support
Modification(s)
|
Central Council for Research in Ayurvedic Sciences, Jawaharlal Nehru Anusandhan Bhawan, 61-65 Institutional Area, Janakpuri, Delhi-58 |
|
Primary Sponsor
|
Name |
Central Council for Research in Ayurvedic Sciences |
Address |
Institutional Area, Opposite D block, Janakpuri, 110058 |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
Name |
Address |
Ministry of AYUSH |
GPO COMPLEX INA DELHI 110023 |
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 19 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Ranjita Ekka |
Central Ayurveda Research Institute for Drug Development |
4-CN Block, Sector – V, Bidhannagar, Kolkata North Twentyfour Parganas |
7086510816
drranjitaekka@gmail.com |
Dr Sandip Kumar Ramjivan Baheti |
Central Ayurveda Research Institute for Respiratory Disorders |
Moti Bagh Road, Patiala Patiala |
9422540609
sandiprbaheti@gmail.com |
Dr K Prameela Devi |
Dr. Achanta Lakshmipati Research Centre for Ayurveda |
Arignar Anna Government Hospital Campus, Arumbakkam, Chennai Chennai |
9445812604
kprameel@gmail.com |
Dr Sanjay Kumar |
National Ayurveda Research Institute for Panchakarma |
Cheruthuruthy, Thrissur Malappuram |
9446090579
drsanjayayr@yahoo.com |
Dr Sanjay Kumar |
National Ayurveda Research Institute for Panchakarma |
Cheruthuruthy, Thrissur Palakkad |
9446090579
drsanjayayr@yahoo.com |
Dr Sneha Marlewar |
Raja Ramdeo Anandilal Podar (RRAP) Central Ayurveda Research Institute for Cancer |
Podar Medical Campus, Dr. Annie Besant Road, Worli, Mumbai Mumbai |
9119449316
drsnehamarlewar@gmail.com |
Dr Deepa Sharma |
Regional Ayurveda Research Institute for Drug Development |
Amkho (Kampoo), Gwalior Gwalior |
9450109125
sha.dpa@gmail.com |
SK Vedi |
Regional Ayurveda Research Institute for Endocrine Disorders |
Jhotwara Road Banipark Jaipur Jaipur |
9958426086
drskvedi@gmail.com |
Suhas A Chaudhary |
Regional Ayurveda Research Institute for Endocrine Disorders |
Jhotwara Road Banipark Jaipur Bhilwara |
9427073351
vdsuhaschaudhary@gmail.com |
DrAlok Kumar Srivastava |
Regional Ayurveda Research Institute for Eye Diseases |
NS-106, Sector-25, Indira Nagar, Lucknow Lucknow |
9661131027
drakspatt@gmail.com |
Dr PL Bharati |
Regional Ayurveda Research Institute for Gastro-Intestinal Disorders |
Borsojai, Beltola, Guwahati Marigaon |
9407587686
plbharati@rediffmail.com |
Dr DSRotwar |
Regional Ayurveda Research Institute for Infectious Diseases |
RMRI Building “D” Block, Agam Kuan, Patna Gaya |
7987135761
dsrotwar7@gmail.com |
Dr Kuldeep |
Regional Ayurveda Research Institute for Infectious Diseases |
RMRI Building “D” Block, Agam Kuan, Patna Patna |
8954354560
doc.kuldeep@gmail.com |
Dr SH Doddamani |
Regional Ayurveda Research Institute for Metabolic Disorders |
#12, Uttarahalli Manavarthe Kaval, Uttarahalli (Hobli), Bangalore South (Tq.) Kanakapura Main Road, Talaghattapura Post, Bengaluru Bangalore |
9448085818
shd_ayu@yahoo.co.in |
Dr Savita Sharma |
Regional Ayurveda Research Institute for Mother and Child Health |
Near Gharkul Parisar, Near Venkatesh Nagar, NIT Complex
Nandanwan, Nagpur
Nagpur |
8149526366
savitashirish@yahoo.co.in |
DrKavita Mansukhbhai Vyas |
Regional Ayurveda Research Institute for Nutritional Disorders |
Gandhi Bhawan, Mandi Mandi |
9888552911
kavitakrishu@gmail.com |
Dr Anil Avhad |
Regional Ayurveda Research Institute for Skin Disorders |
Block A & D, 2nd Floor, Bahumali Bhavan, Manjushree Mill Compound, Near Girdharnagar Over Bridge, Asarwa, Ahmedabad Ahmadabad |
9510176085
anilavhad4u@gmail.com |
Dr C Muralikrishna |
Regional Ayurveda Research Institute for Skin disorders |
New Rajiv Nagar, Payakapuram, Vijayawada Krishna |
8309859317
mkchagamreddy@gmail.com |
Dr Paikrao Sumed |
Regional Ayurveda Research Institute for Skin Disorders |
Block A & D, 2nd Floor, Bahumali Bhavan, Manjushree Mill Compound, Near Girdharnagar Over Bridge, Asarwa, Ahmedabad Surendranagar |
7698825705
sampaikrao27@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Central Ethical Committee |
Approved |
Central Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy volunteers in containment zones of COVID 19 |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
guduchi Ghan Vati/Samshamani Vati |
1 gm per person/day, 500 mg two times (BID) for 30 days. Route would be oral
|
Comparator Agent |
Hand sanitizer
Face Mask
Social Distancing |
To be complied as per the central/state guidelines |
|
Inclusion Criteria
Modification(s)
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Participants who are from a community where at least 1 confirmed case is already identified.
2. Participants who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study
|
|
ExclusionCriteria |
Details |
• Known cases Covid-19.
• Pregnant and Lactating females
• Known cases of uncontrolled Diabetes and Hypertension
• Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
• Participants having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc.
• Participants taking Steroid treatment and or any kind of immunosuppressive therapy
• Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.
• Participants having a history of allergy to any medicine that is part of the Ayurvedic intervention.
• Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Comparative assessment of occurrence of COVID-19 infection in Clinically stable participants in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care |
0, two weeks, 4 weeks, 6 weeks. |
|
Secondary Outcome
Modification(s)
|
Outcome |
TimePoints |
Comparative assessment of severity of COVID-19 infection in participants taking Guduchi Ghan Vati/ Sudarshan Ghan Vati and the control arm in following situations:
1. Assessment of participants not requiring hospitalization
2. Severity of symptoms of hospitalized patients in wards
3. Patients requiring ICU admission / Ventilator support
4. Global assessment of overall change as per the investigator (Efficacy assessment)
|
Total 45 days (0, 2, 4, 6 weeks) |
|
Target Sample Size
Modification(s)
|
Total Sample Size="30000" Sample Size from India="30000" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/06/2020 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
Brief Summary
Modification(s)
|
In view of the unavailability of any vaccine / successful treatment strategy for management of COVID-19 infection as on date, there is a need to investigate and explore potential medical interventions or to develop novel drugs that can contain the outbreak, It is imperative that to cater to such a huge population there should be a research on Traditional Systems of Medicine also, as these systems are co-existing with the lifestyles of the people in that particular geographical region. the objective of this study is Comparative assessment of Guduchi Ghan Vati/ Sudarshan Ghan Vati intake in prophylaxis of COVID-19, with control arm of Standard Prophylactic Care in containment zone population.
This clinical study is a multicentre trial intended to be executed in selected containment zones across 20 districts of India. The study is non-randomized controlled clinical trial involving a total sample size of 30,000 with 20, 000 in intervention arm and 10,000 in control arm. The duration of intervention is 45 days and the total duration of the study is 3 months. The outcome measure is Comparative assessment of occurrence of COVID-19 infection in Clinically stable participants in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care and comparative assessment of severity of COVID-19 infection in participants. |