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CTRI Number  CTRI/2025/06/088614 [Registered on: 11/06/2025] Trial Registered Prospectively
Last Modified On: 11/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to understand the efficacy of derma roller in patients suffering from patterned hair fall 
Scientific Title of Study   A randomized controlled clinical study to evaluate the efficacy of prachanna karma using derma roller in the management of khalitya vis-a-vis androgenic alopecia 
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 JAYANTHI K S 
Designation  PG Scholar 
Affiliation  Muniyal institute of ayurveda medical sciences, Manipal 
Address  outpatient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi

Udupi
KARNATAKA
576104
India 
Phone  9113697110  
Fax    
Email  jashi1954@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gururaja D 
Designation  Professor 
Affiliation  Muniyal institute of ayurveda medical sciences, Manipal 
Address  outpatient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi

Udupi
KARNATAKA
576104
India 
Phone  8762822790  
Fax    
Email  gurushalya@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Jayanthi K S 
Designation  PG scholar 
Affiliation  Muniyal institute of ayurveda medical sciences, Manipal 
Address  outpatient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi

Udupi
KARNATAKA
576104
India 
Phone  9113697110  
Fax    
Email  jashi1954@gmail.com  
 
Source of Monetary or Material Support  
Muniyal institute of ayurveda medical sciences, manipal 
 
Primary Sponsor  
Name  Muniyal institute of ayurveda medical sciences, manipal 
Address  Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi - 576104 
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 
Dr Jayanthi K S  Muniyal institute of ayurveda medical sciences, Manipal  outpatient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi
KARNATAKA 		 9113697110

jashi1954@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Muniyal institute of ayurveda institutional ethics committee  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-pracCAnam, प्रच्छानम् (Procedure Reference: Susrutha samhitha , chikitsa sthana 20th chapter, 24-27th sloka, Procedure details: Prachanna karma once in 7days for 4sittings with derma roller followed by patola patra lepa application)
2Comparator Arm (Non Ayurveda)-Derma rollerDerma roller with a needle thickness of 0.5mm
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Age between 18-60years
2) Patients of either sex
3) Patients having patterned hair loss occurring on the scalp. 
 
ExclusionCriteria 
Details  1) Patients with any other type of alopecia like alopecia totalis, alopecia universalis & alopecia areata.
2) Patients suffering from other scalp diseases like tineacapitis, trichotillomania and traumatic alopecia.
3) Abnormal bleeding and clotting time.
4) Immunocompromised patients with prediagnosed HIV and HbsAg positve
5) Patient suffering from any systemic diseases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Breaking keratinized epithelium stimulates growth factors  1 sitting 
 
Secondary Outcome  
Outcome  TimePoints 
Encourages hair growth  3/4 sittings 
 
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   N/A 
Date of First Enrollment (India)   23/06/2025 
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="4"
Days="20" 
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 - NO
Brief Summary  
Hair serves multiple essential functions for humans including its aesthetic appeal. Khalitya is explained as one of the kshudra rogas by Acharya sushruta, kapala gata roga by Acharya Vagbhatta. Acharya sushruta describes prachanna karma as a treatment modality for Khalitya.
While insulin needle is widely used for prachanna karma in practice, Derma roller offers several advantages in terms of precision, consistency, coverage without overlapping incisions, ease of use and customisation in needle size and length, making them a preferred option over regular insulin needles.
Male and female pattern baldness, Androgenic alopecia which is not just a skin appendage disorder as it have a great impact on psychological aspects of individual’s life, including self-esteem, body image, social interaction and social anxiety. Where as Khalitya can be regarded as the hetu for manasa shalya - shoka.
Early detection and intervention are crucial in Khalitya (androgenic alopecia) for preventing the condition, preserving the existing hair, improving treatment outcomes, enhancing psychological well-being, tailoring treatment plans, and avoiding further complications
 
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