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CTRI Number  CTRI/2020/05/025385 [Registered on: 27/05/2020] Trial Registered Prospectively
Last Modified On: 27/05/2020
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 = 20  
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 
DrVilas Gangurde  Regional Ayurveda Research Centre  Dimapur, Nagaland-797112
Dimapur
 
9422356656

drvilas156@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  
Status 
Not Applicable 
 
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   Total Sample Size="40000"
Sample Size from India="40000" 
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)  Not Yet Recruiting 
Publication Details
Modification(s)  
Nil 
Brief Summary   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 40,000 with 20, 000 each in intervention arm and 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.  
 

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