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CTRI Number  CTRI/2025/08/092769 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on the use of herbal oil nasal therapy and derma roller system treatment for early hair loss 
Scientific Title of Study   Assessment of nilibhringadi taila nasya karma and derma roller system in management of akal khalitya Randomized controlled clinical trial 
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 Shubhangi Rajendra Girnale 
Designation  MD Scholar Panchakarma Department 
Affiliation  CSMSS Ayurved Mahavidyalaya and Rugnalaya 
Address  OPD No.15 of Panchakarma Department,CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  8459484763  
Fax    
Email  shubhangi.girnale19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrRamesh D Sonwane 
Designation  Associate Professor ,Panchakarma Department 
Affiliation  CSMSS Ayurved Mahavidyalaya and Rugnalaya 
Address  OPD No.15 of Panchakarma Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  09579773404  
Fax    
Email  ramesh10673@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubhangi Rajendra Girnale 
Designation  MD Scholar Panchakarma Department 
Affiliation  CSMSS Ayurved Mahavidyalaya and Rugnalaya 
Address  OPD No 15 of Panchakarma Department CSMSS Ayurved Mahavidyalaya and Rugnalaya

Aurangabad
MAHARASHTRA
431001
India 
Phone  08459484763  
Fax    
Email  shubhangi.girnale19@gmail.com  
 
Source of Monetary or Material Support  
CSMSS Ayurved Mahavidyalay and Rugnalaya kanchanwadi paithan road Aurangabad 431011 Maharashtra India 
 
Primary Sponsor  
Name  Dr Shubhangi Rajendra Girnale 
Address  OPD No 15 of Panchakarma Department CSMSS Ayurved Rugnalaya kanchanwadi Aurangabad 431011 Maharashtra India  
Type of Sponsor  Other [Self] 
 
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 Shubhangi Rajendra Girnale  CSMSS Ayurved mahavidyalay and Rugnalaya kanchanwadi Aurangabad  OPD No.15 of Panchakarma Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya,Kanchanwadi,Aurangabad
Aurangabad
MAHARASHTRA 
08459484763

shubhangi.girnale19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CSMSS Ayurved mahavidyalay and Rugnalaya kanchanwadi Aurangabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: KHALITYAM/KHALATI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marSaH, मर्श (Procedure Reference: Ashtanga Hrudaya Charak Samhita Shushrut samhita, Procedure details: The procedure purva karma includes gentel facial massage and fomentation. In Pradhan karma the neelibhringadi taila 4ml instillation procedure is done into each nostril while patient in supine position with head low position in post procedure light massage of feet shoulders palms ears and fomentation will be done and patient will be asked to expel out the oil which comes in oropharynx )
(1) Medicine Name: Nilibhringadi Taila, Reference: Shasrayogam tailadi varga, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtanga Hurdaya Charak Samhita Shushrut samhita, Procedure details: The procedure purva karma includes gentel facial massage and fomentation. In Pradhan karma the madhukyadi taila instillation procedure will be done into each nostril while patient in supine position with head low position in post procedure light massage of feet shoulders palms ears and fomentation will be done and patient will be asked to expel out the oil which comes in oropharynx)
(1) Medicine Name: Madhukyadi Taila, Reference: Vangsen samhita, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient with symptoms of hair fall itching of scalp visibility of scalp.
Patients who are fit for nasya karma and pracchan karma
willingness to follow the study protocol with written consent. 
 
ExclusionCriteria 
Details  Patients diagnosed with alopecia areata alopecia totalis universalis tinia capitis
ANC or lactating mothers as potential saftey concern
Nasya Ayoya
Patients diagnosed with CA hormonal disorders hypo or hyper thyroidism and low hb level 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduced hair fall
promote new hair growth 
Baseline 0th day 8th day 21st day 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improved scalp health Improved hair texture and shine and strength  Baseline 0th day 8th day 21st day 30th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   19/08/2025 
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="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  
Akal Khalitya (premature hair loss) is a rising concern in younger populations, with significant psychological and cosmetic impacts. In Ayurveda, Khalitya is classified under Shiroroga and is associated with doshic imbalances affecting scalp health and hair follicle function. Nasya Karma, a therapeutic nasal administration, is a classical treatment for head-related disorders, promoting dosha balance and hair regrowth. Nilibhringadi Taila, a classical herbal formulation, is known for its keshya (hair-promoting) properties. Modern dermatology increasingly uses microneedling via Derma Roller to enhance scalp circulation and stimulate hair follicles, usually paired with chemical agents like minoxidil, which often cause side effects.

This study explores a holistic, side-effect-free approach by combining Nasya Karma with Nilibhringadi Taila and Derma Roller System to manage Akal Khalitya. It aims to assess their synergistic effect on promoting hair regrowth, improving scalp health, and offering a safer alternative to conventional treatments. The study addresses existing gaps in research comparing different forms of Nasya and evaluates the efficacy of external therapies when integrated with classical Ayurvedic interventions.
This study explores a holistic Ayurvedic approach combining Nasya Karma (therapeutic nasal administration) using Nilibhringadi Taila (a classical herbal oil formulation) with Derma Roller therapy (a modern microneedling technique) to stimulate hair regrowth. Nilibhringadi Taila is known for promoting hair growth and scalp nourishment. Derma Roller enhances absorption and activates hair follicles.
The aim is to assess the safety and efficacy of this combined protocol in individuals suffering from premature hair loss and to provide a natural, side-effect-free alternative to modern therapies.

 
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