| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm | Procedure | - | 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 |
|
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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 |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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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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