| CTRI Number |
CTRI/2026/03/106057 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study to evaluate effect of Herbal nasal therapy and Herbal Paste in the management of Hair loss. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to Assess the Effectiveness of Haridradi Lepa and Yastimadhu Taila Nasya in the Management of Khalitya |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharan Murthy P R |
| Designation |
PG SCHOLAR |
| Affiliation |
Muniyal Institute Of Ayurveda Medical Sciences |
| Address |
Out patient ward department of panchakarma, ground floor, room no.3, Muniyal Institute Of Ayurveda Medical Sciences 34-C, Shivalli, Industrial Area, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9972225836 |
| Fax |
|
| Email |
sharan20pujar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Guruprasad G |
| Designation |
Professor |
| Affiliation |
Muniyal Institute Of Ayurveda Medical Sciences |
| Address |
Out patient ward department of panchakarma, ground floor, room no.3, Muniyal Institute Of Ayurveda Medical Sciences 34-C, Shivalli, Industrial Area, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844632505 |
| Fax |
|
| Email |
shettydrguruprasad@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sharan Murthy P R |
| Designation |
PG SCHOLAR |
| Affiliation |
Muniyal Institute Of Ayurveda Medical Sciences |
| Address |
Out patient ward department of panchakarma, ground floor, room no.3, Muniyal Institute Of Ayurveda Medical Sciences 34-C, Shivalli, Industrial Area, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9972225836 |
| Fax |
|
| Email |
sharan20pujar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Muniyal Institute Of Ayurveda Medical Sciences |
| Address |
Muniyal Institute Of Ayurveda Medical Sciences, shivalli, industrial area, manipal, udupi,576104, karnataka,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sharan Murthy P R |
Muniyal Institute Of Ayurveda Medical Sciences |
Out patient ward department of panchakarma, ground floor, room no.3, Muniyal Institute Of Ayurveda Medical Sciences 34-C, Shivalli, Industrial Area, Manipal
Udupi
KARNATAKA |
9972225836
sharan20pujar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muniyal Institute Of Ayurveda Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Vagbhata, Procedure details: Medicinal drug will be administered for 7 days with appropriate pre procedure & post procedure regimen.)
(1) Medicine Name: Yashtimadhu Taila, Reference: Vangasea, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: keraliya chikitsa padati, Procedure details: The paste, is first applied to the crown of the head, followed by the front, sides, & back in a sequential manner, ensuring complete coverage of the scalp. The applied layer should be approximately 1/3rd part of thickness. Finally, the head is covered with a banana leaf & a cloth band is securely tied around the forehead to prevent the medicinal paste from dripping downward. The Lepa is kept for 48 minutes.)
(1) Medicine Name: haridradi lepa, Reference: Rasaratna samucchaya, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 50(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with characteristic symptoms of Khalitya
2.Patients belonging to the 18 – 40 age group of both sexes
3.Patients suitable for Nasya therapy and Lepa. |
|
| ExclusionCriteria |
| Details |
1.Patients who have diseases like Tinea capitis, folliculitis decalvans and in ayurvedic terms
patients of Arumshika, Indralupta.
2.Patient suffering from any systemic diseases like Hypothyroidism, Carcinoma etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in hair fall, Improvement in regrowth in affected scalp area. |
14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in hair Thickness, strength. |
14th day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="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 plays a vital role in an individual’s appearance and personality, and the condition of the hair and scalp significantly affects psychological well-being and self-confidence. In Ayurveda, Acharyas have described the origin of hair in relation to Charaka Samhita, where hair is considered a Mala of Asthi Dhatu, while Sharngadhara Samhita describes it as an Upadhatu of Asthi. Ayurvedic classics explain several hair disorders such as Khalitya (hair fall), Palitya (premature greying), Indralupta (alopecia areata), and Darunaka (dandruff), mainly caused by the imbalance of the three Doshas—Vata, Pitta, and Kapha. Khalitya has been classified under Shiroroga by Acharya Charaka and Acharya Vagbhata, while Acharya Sushruta described it under Kshudraroga. In modern medicine, it corresponds to alopecia or baldness, characterized by partial or complete hair loss from the scalp. The prevalence of Khalitya is increasing due to factors such as unhealthy lifestyle, improper diet, irregular sleep, stress, diseases, and medications. Classical Ayurvedic treatments include Nasya and Lepa as mentioned in Charaka Samhita. This study aims to compare the therapeutic efficacy of Yashtimadhu Taila Nasya and Haridra Lepa in the management of Khalitya |