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CTRI Number  CTRI/2022/10/046368 [Registered on: 11/10/2022] Trial Registered Prospectively
Last Modified On: 27/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Other 
Public Title of Study   Effect of Chawayan Shakti Powder(An Ayurvedic polyherbal combination) in improving physical health and immunity. 
Scientific Title of Study   “A Clinical study to evaluate the safety and efficacy of Chawayanshakti Powder as physical health and immunity booster”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Vijay Chaudhary 
Designation  Principal 
Affiliation  R.G.Govt P.G Ayurvedic College Paprola 
Address  Administrative block, room No. 1 Majherna Road, Paprola H.P 176115

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418130228  
Fax    
Email  drvijaychaudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manik Soni 
Designation  Lecturer 
Affiliation  Rajiv gandhi Govt P.G Ayurvedic College Paprola 
Address  PG deptt of Kaya Chikitsa, R.G.Govt.P.G Ayurvedic College, Majherna Road, Paprola h.P 176115

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9816842425  
Fax    
Email  drmsony@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manik Soni 
Designation  Lecturer 
Affiliation  Rajiv gandhi Govt P.G Ayurvedic College Paprola 
Address  PG deptt of Kaya Chikitsa, R.G.Govt.P.G Ayurvedic College, Majherna Road, Paprola h.P 176115

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9816842425  
Fax    
Email  drmsony@gmail.com  
 
Source of Monetary or Material Support  
KAG Industries, Nahan Road, Kala Amb, H.P 173030 
 
Primary Sponsor  
Name  KAG Industries, Nahan H.P 
Address  Vill Moginand, Nahan road, Kala Amb H.p 173030 
Type of Sponsor  Other [Food Manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Vijay Chaudhary  Rajiv gandhi Govt P.G Ayurvedic Hospital Paprola H.P  Room No. 317, Department of kaya Chikitsa, Rajiv Gandhi Govt P.G Ayurvedic Hospital, Majherna Road, Paprola h.P 176115
Kangra
HIMACHAL PRADESH 		 09418130228

drvijaychaudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (Human)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  general well being and immunity 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Chawayan Shakti, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  healthy individuals in the age group of 18-65 years willing for trial and able to come for follow up. 
 
ExclusionCriteria 
Details  individuals who are unwilling for trial or below 18 and above 65 years of age or having any concomitant illness requiring medical intervention. individuals allergic to milk or components of Chawayan shakti powder. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increase in hemoglobin and IgG and IgM  at baseline, 15 days and 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical safety and tolerability of Chawayan Shakti powder as seen by its effecs on renal function and Liver enzymes.   15 days and 30 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   17/10/2022 
Date of Study Completion (India) 09/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drvijaychaudhary@gmail,com].

  6. For how long will this data be available start date provided 31-03-2023 and end date provided 04-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  		 Chawayan Shakti is a polyherbal ayurvedic drug which is intended to be used as a general health tonic and immunobooster. The contents of the drug are well known for their Rasayana or antioxidant properties as well as immunity boosting effects. The present study is to validate the efficacy of this drug and also to evaluate its safety and tolerability in general population. 
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