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CTRI Number  CTRI/2025/03/082247 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Asthi Pradoshaja Vikara (Khalitya) and its Management Using Dhurdhuradi Taila (Topical) and Chandanadya Taila (Nasya) 
Scientific Title of Study   Conceptual and Applied Study of Asthi Pradoshaja Vikara w.s.r. to Khalitya and its Management with Dhurdhuradi Taila Topically and Chandanadya Taila Nasya 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Rajesh Kumar Sood 
Designation  Professor 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 
Address  Room no. 405 Department of Samhita Siddhant and Sanskrit, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra HIMACHAL PRADESH 176115 India

Kangra
HIMACHAL PRADESH
176115
India 
Phone  7018785200  
Fax    
Email  drrajeshsood@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Rajesh Kumar Sood 
Designation  Professor 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 
Address  Room no. 405 Department of Samhita Siddhant and Sanskrit, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra HIMACHAL PRADESH 176115 India

Kangra
HIMACHAL PRADESH
176115
India 
Phone  7018785200  
Fax    
Email  drrajeshsood@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kamini Verma 
Designation  PG Scholar 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 
Address  Room no. 407 Department of Samhita Siddhant and Sanskrit, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra HIMACHAL PRADESH 176115 India

Kangra
HIMACHAL PRADESH
176115
India 
Phone  7807174753  
Fax    
Email  kaminiverma89888@gmail.com  
 
Source of Monetary or Material Support  
Charak Pharmacy, RGGPG Ayurvedic College and Hospital Paprola District Kangra Pin code 176115 H.P. Research Institute in I.S.M JoginderNagar Dist. Mandi Pin code 175015 H.P. 
 
Primary Sponsor  
Name  RGGPG Ayurvedic College 
Address  Rajiv Gandhi government post graduate ayurvedic College and Hospital, Paprola Himachal Pradesh 
Type of Sponsor  Research institution and hospital 
 
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 Dr Rajesh Kumar Sood  Rajiv Gandhi government post graduate ayurvedic College and Hospital, Paprola Himachal Pradesh  OPD no. 715 Skin Care Unit Derma Research Lab Hospital block Kangra HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH 		 7018785200

drrajeshsood@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC(Human)RGGPG Ayurvedic College Paprola  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L649||Androgenic alopecia, unspecified. Ayurveda Condition: KHALITYAM/KHALATI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Siro~aBya~ggaH, शिरोरऽभ्यंग (Procedure Reference: Charaka Samhita chapter 5/81-83/, Procedure details: )
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charaka Samhita siddhisthan 9/117, Procedure details: The patient will be advised to take Chandanadya Pratimarsha Nasya (2 Bindu in each nostril)in lying position in the morning and at bedtime along with Dhurdhuradi taila topically over the scalp at bedtime regularly for a month. )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients willing to participate in the trial.
Patients having the following signs and symptoms:
1.Kesha Patana(Diffuse hair fall)
2.Kesha Rukhshatva(Roughness)
3.Daha(Burning sensation on scalp)
Patients between 18 and 50 years of age.
All the patients will be examined and assessed by detailed case history.
 
 
ExclusionCriteria 
Details  1.Patients not willing to participate in the clinical study.
2.Patients below 18 years and above 50 years of age.
3.Patients having local diseases like Tinea capitis, Scalp Psoriasis and Seborrhic dermatitis.
4.Pregnant and Lactating women.
5.Patients not ready to give informed consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The overall improvement which will be shown by the patients in signs and symptoms of Khalitya.  30 days, Follow up every 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
The overall improvement which will be shown by the patients in signs and symptoms of Khalitya.  60 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 4 
Date of First Enrollment (India)   01/05/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Hair is linked with an individual’s sense of worth, personal style and self-confidence. Khalitya, characterized by widespread hair loss, is understood in Ayurveda as a disturbance caused by an imbalance of the body’s Doshas, particularly Pitta, often in conjunction with Vata or Kapha. The Ayurvedic texts describe various disorders arising from the vitiation of the Asthi Dhatu, with Khalitya being a prominent manifestation. Charaka considered Kesha (scalp hair) and Loma (body hair) as Mala(waste products) of metabolism of Asthi Dhatu. The study aims to explore the Ayurvedic view of Asthipradoshaja Vikara, study the pathogenesis and management of Khalitya (diffuse hair fall) in relation to Asthi Dhatu, and assess the clinical outcomes of topical application of Dhurdhuradi Taila alone and in combination with Chandanadya Taila Nasya. 

 
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