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CTRI Number  CTRI/2022/11/047080 [Registered on: 07/11/2022] Trial Registered Prospectively
Last Modified On: 05/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effects Of Aaditya Pak Guduchi Tail Shiroabhyang in Khalitya(Baldness) 
Scientific Title of Study   A Clinical Study To Evaluate The Efficacy Of Aaditya Pak Guduchi Tail Shiro Abhyang In Management Of Khalitya (Baldness) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ghyan kanwar 
Designation  MD Scholar 
Affiliation  University Post Graduate Institute Of Ayurved Studies and Research  
Address  PG Department Of Swasthvritta and Yoga University Post Graduate Institute Of Ayurved Studies and Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  8561922986  
Fax    
Email  ghyan22solanki@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod Kumar Mishra 
Designation  HOD AND PROFESSOR 
Affiliation  University Post Graduate Institute of Ayurved Studies and Research Jodhpur 
Address  PG Department Of Swasthvritta and Yoga Uviversity Post Graduate Institute Of Ayurved Studies and Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  9001009793  
Fax    
Email  drpramodmishra4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ghyan kanwar 
Designation  P G SCHOLAR 
Affiliation  University Post Graduate Institute of Ayurved Studies and Research Jodhpur 
Address  PG Department Of Swasthvritta and Yoga Uviversity Post Graduate Institute Of Ayurved Studies and Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  8561922986  
Fax    
Email  ghyan22solanki@gmail.com  
 
Source of Monetary or Material Support  
PG Department of Swasthvritta and Yoga UPGIASR Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Jodhpur 
 
Primary Sponsor  
Name  UPGIASR Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Jodhpur  
Address  PG Department of Swasthvritta and Yoga UPGIASR Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Jodhpur  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Ghyan Kanwar  PG Department of Swasthvritta and Yoga UPGIASR Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Jodhpur  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ghyan kanwar  UPGIASR  PG Department of Swasthvritta and Yoga UPGIASR Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Jodhpur
RAJASTHAN 		 8561922986

ghyan22solanki@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Of Ethics Committee University Post Graduate Institute of Ayurved Studies and Research Jodhpur Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: KHALITYAM/KHALATI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Siro~aBya~ggaH, शिरोरऽभ्यंग (Procedure Reference: Cha.sutra.5/81-83, Procedure details: Aaditya pak guduchi Tail Shiroabhyang 30 min per day)
(1) Medicine Name: Aaditya pak guduchi Tail , Reference: Chd.kshudra roga chik.54/107, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 90 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Patients aged between 20 to 40 years irrespective of their caste, race and sex etc.
2 Patients having the clinical features of Khalitya.
3 Patients belonging to both genders will be included.
4 Patient with the sign & symptoms of Khalitya as mentioned in Ayurveda text.
 
 
ExclusionCriteria 
Details  1 Patients age below 20 and above 40 years.
2 Patients suffering from any severe systematic disease.
3 Necessary step was taken to exclude other condition as per facilities available in the institute.
4 Patients having history of hair loss due to injury.
5 Patients who are using artificial gels, dyes, shampoos etc.
6 Patients who have been diagnosed to have local disease like-Alopecia areata, Alopecia totalis.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Subjective and Objectives Parameters   90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Aaditya Pak Guduchi Tail In Khalitya(Baldness)  90 DAYS 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   07/11/2022 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Hair fall changes the outer look of a person, which becomes embarrassing and more conscious and is being forced to undergo various and more expensive treatment like hair transplant in modern science. Different types of steroids are being prescribed for the management of hair fall continuous and long term of which is having various adverse effects. In such a scenario there is a need for the efficient management of hair fall in a natural way without leading to further adverse effects. Ayurveda classics explain different modality for the management of Khalitya (hair fall). Pitta is the Pradhan Doshas contributing to Khalitya (hair fall).
Health of an individual is deeply influenced by the environmental factors and lifestyle. Nowadays lifestyle diseases are more. Because of this increasing prevalence in the society, they need more attention.
 
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