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CTRI Number  CTRI/2025/01/079719 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 28/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study on efficacy of oral Ayurvedic formulation (Bhringarajadi Rasayana) in Gray Hairs at age group of 20 to 30 years individuals. 
Scientific Title of Study   A Single Arm Clinical study to evaluate the effect of Bhringarajadi Rasayana in Akala Palitya (Premature Graying of Hair) in different Deha Prakriti individuals 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogesh Shewale 
Designation  Ph. D. Scholar 
Affiliation  Sumatibhai Shaha Ayurved Mahavidyalaya Hadapsar Pune 
Address  Assistant Professor, Kriya Sharir Department, 1st floor, Government Ayurvedic College Osmanabad (Dharashiv), Tuljapur Road, Osmanabad

Osmanabad
MAHARASHTRA
413501
India 
Phone  9028148202  
Fax    
Email  yogeshshewale007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaishali Bhosale 
Designation  Associate Professor and Guide 
Affiliation  Sumatibhai Shaha Ayurved Mahavidyalaya Hadapsar Pune 
Address  Kriya Sharir Department, 2nd Floor, Sumatibhai Shaha Ayurved Mahavidyalaya Hadapsar, Malvadi, Pune

Pune
MAHARASHTRA
411028
India 
Phone  9762625038  
Fax    
Email  drvaishali.bhosale@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yogesh Kashinath Shewale 
Designation  Ph. D. Scholar 
Affiliation  Sumatibhai Shaha Ayurved Mahavidyalaya Hadapsar Pune 
Address  Kriya Sharir Department, 2nd floor, Sumatibhai Shaha Ayurved Mahavidyalaya Hadapsar, Malvadi, Pune

Pune
MAHARASHTRA
411028
India 
Phone  9028148202  
Fax    
Email  yogeshshewale007@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Yogesh Kashinath Shewale 
Address  Ph. D. Scholar, Kriya Sharir Department, 2nd floor, Sumatibhai Shaha Ayurved Mahavidyalaya Hadapsar, Malvadi, Pune, Maharashtra, India. Pin code 411028 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogesh Shewale  Government Ayurvedic College Osmanabad  Assistant Professor, Kriya Sharir Department, 1st floor, Government Ayurvedic College Osmanabad, Tuljapur Road, Osmanabad
Osmanabad
MAHARASHTRA 		 9028148202

yogeshshewale007@gmail.com 
Dr Yogesh Shewale  Sumatibhai Shaha Ayurved Mahavidyalaya Hadapsar Pune  Kriya Sharir Department, 2nd Floor, Sumatibhai Shaha Ayurved Mahavidyalaya Hadapsar Pune
Pune
MAHARASHTRA 		 9028148202

yogeshshewale007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee, Government of Maharashtra office of the Dean, Govt. Ayurvedic college, Tuljapur Road, Osmanabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Having Graying of hair with age group 20 to 30 years 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Bhringarajadi Rasayana, Reference: Bhaishajya Ratnavali, Rasayana Adhikara, Chapter No. 73, Sloka no. 28-29, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: Fine powder of 2 parts of Bhringaraja choorna, 1 part of Krishnatila choorna, 1 part of Amalaki choorna and 4 parts of Sharkara (Sugar) are taken and mixed together. This is administered with Ushnodaka
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Volunteers having features of Graying of Hairs are selected randomly irrespective of their gender, education, socio-economic status and religion.
 
 
ExclusionCriteria 
Details  Volunteers suffering from any severe systemic illness like Diabetes mellitus, Hypertension, Thyroid disorders, AIDS etc.
Graying of Hairs associated with the diseases of pigmentation like Vitiligo, Leprosy and Albinism.
Infectious diseases of scalp like Alopecia Areata.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of Bhringarajadi Rasayana in Graying of Hairs in different Deha Prakriti Individuals.  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the prevalence of Akala Palitya in different Deha Prakriti Individuals  12 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 
Date of First Enrollment (India)   17/02/2025 
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="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [yogeshshewale007@gmail.com].

  6. For how long will this data be available start date provided 17-02-2025 and end date provided 15-04-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is single arm clinical trial, open labelled, non randomized on age group 20 to 30 years having Graying of Hairs. The efficacy of Bhringarajadi Rasayana Churna was checked after admistered for 90 days in OD dose in volunteers having different Deha Prakriti. 
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