CTRI Number	CTRI/2020/06/025525 [Registered on: 01/06/2020] Trial Registered Prospectively
Last Modified On:	01/06/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Drug Ayurveda Preventive
Study Design	Other
Public Title of Study	Guduchi Ghanavati as a prophylactic measure among population at high risk to SARS-CoV-2 exposure
Scientific Title of Study	A prospective non-randomised open label controlled interventional study on the effect of Guduchi Ghanavati as a prophylactic measure among population at high risk to SARS-CoV-2 exposure
Secondary IDs if Any Modification(s)	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Anup Thakar  Address  Director office IPGTRA GAU Jamnagar Jamnagar GUJARAT 361008 India  Phone     Fax     Email  directoripgt@ayurveduniversity.com
Details Contact Person Scientific Query	Name  Kalpesh Panara  Address  Department of Dravyaguna IPGTRA Jamnagar Jamnagar GUJARAT 361008 India  Phone     Fax     Email  kbpanara@gmail.com
Details Contact Person Public Query	Name  Kalpesh Panara  Address  Department of Dravyaguna IPGTRA Jamnagar Jamnagar GUJARAT 361008 India  Phone     Fax     Email  kbpanara@gmail.com
Source of Monetary or Material Support Modification(s)	Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Primary Sponsor	Name  Institute for Post Graduate Teaching and Research in Ayurveda  Address  Opp city B division Police station Gujarat Ayurved University Jamnagar  Type of Sponsor  Research institution and hospital
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 5   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Harshit Shah  Akhandanand Ayurveda college  Principal office Shalya Department Akhandanand Ayurveda college Bhadra Near alice bridge Ahmedabad Ahmadabad   9824068760 akhandanandprincipal@gmail.com  Bharat Kalsariya  Government Ayurveda College Vadodara   Principal office Rasa Shastra Department Government Ayurveda college Panigate Vadodara Vadodara   8141854828 drbharat1977@gmail.com  Anup Thakar  IPGTRA  Director office 1st floor Institute building IPGTRA Gujarat Ayurved University Jamnagar Jamnagar   9978403323 directoripgt@ayurveduniversity.com  Naresh Jain  Sheth J P Government Ayurved College  Principal office Sheth J P Government Ayurved College Panvadi Chouk Bhavnagar Bhavnagar   7359361933 jpgovt@gmail.com  Sweety Ruparel  State Model Government Ayurved College  Principal office State Model Government Ayurved College Kolavada Gandhinagar Gandhinagar   9429202048 smiaskolavda@gmail.com
Details of Ethics Committee	No of Ethics Committees= 5   Name of Committee  Approval Status  IECIPGTRA  Approved  IECIPGTRA  Approved  IECIPGTRA  Approved  IECIPGTRA  Approved  IECIPGTRA  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Healthy Human Volunteers  Population at high risk for SARS CoV 2 infection
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  Guduchi Ghanavati   2 Pills of 250mg each Orally twice a day with water For 28 days  Comparator Agent  No treatment in control group  As this is prophylaxis study no treatment arm is selected in this study as control group
Inclusion Criteria	Age From  18.00 Year(s) Age To  68.00 Year(s) Gender  Both  Details  Subjects at high risk of exposure to COVID 19 infection such as Health care workers involved in treatment of COVID19 cases Frontline workers of city where COVID 19 cases detected Family members of COVID19 cases or direct contact People in quarantine People in containment zones Subjects who are ready to provide written or digital informed consent and who are willing to participate
ExclusionCriteria	Details  Pregnant and Lactating female COVID 19 positive cases Known cases of uncontrolled Diabetes and Hypertension or any other systemic uncontrolled conditions Having immune compromised status like HIV Hepatitis Tuberculosis Cancer etc Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening Subjects taking Steroid treatment and or any kind of immunosuppressive therapy
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Incidence rate of COVID 19 infection   0 14 28 days
Secondary Outcome	Outcome  TimePoints  Changes in Immune Status Questionnaire   0 14 and 28 days  Changes in WHO QOL BREF  0 14 and 28 days
Target Sample Size	Total Sample Size="20000" Sample Size from India="20000"
Phase of Trial	N/A
Date of First Enrollment (India)	09/06/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details Modification(s)	Nil
Brief Summary	Currently, there is no availability of vaccine against COVID-19 and no drug with proven clinical efficacy. There are several options that might be effective in prevention or treatment. Guduchi (Tinospora cordifolia (Willd.) Miers) is one such important Rasayana drug in Ayurvedic pharmacopeia having wide therapeutic attributes.  It is recommended as Rasayana, Balya (strength), Jwaraghna (anti pyretic) in Ayurvedic classics and used for its anti-inflammatory, immunomodulatory, anti-allergic, antipyretic properties etc.  Clinical efficacy of Guduchi is also evaluated through many clinical studies in different conditions. Guduchi Ghana (concentrated form of Guduchi decoction) is the secondary Kalpana (dosage form) derived from the primary dosage form, i.e. Kwatha (decoction).It is evaluated for its anti-inflammatory, immunomodulatory, anti-microbial, hypoglycemic and anti-hyperglycemic actions in experimental studies. To address these challenges and accelerate the research needed in resource-limited settings, this study is planned to evaluate effect of prophylactic Guduchi Ghana to COVID-19 infection and health status in adult volunteers who are at high risk of exposure.  This study is designed as Open label, non-randomized, interventional, controlled (no treatment group) trial. Method of Sampling is Non probability sampling (convenience sampling method). The total sample size of the study will be 20,000 subjects. These subjects will be divided into 2 groups of 15,000 subjects in trial drug group and 5,000 subjects in control group.