| CTRI Number |
CTRI/2026/03/106248 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Application of Keshnashaka lepa and its modified cream in female patients having facial hair. |
|
Scientific Title of Study
|
Pharmaceutical Analysis and randomised control trial of
keshnashaka lepa and its modified cream in the management of facial hirsutism |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anagha Dhanaraj Ajetrao |
| Designation |
MD scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda college and hospital |
| Address |
Department of Rasashastra and Bhaishjya Kalpana.
Sri Jayendra Saraswathi Ayurveda college and hospital
Nazarathpet Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9303054868 |
| Fax |
|
| Email |
anaghaajetrao99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrB Saravanan |
| Designation |
HOD & Proff |
| Affiliation |
sri Chandrasekharendra Saraswathi viswa Mahavidyalaya University |
| Address |
Department of Rasashastra and Bhaishjya Kalpana.
Sri Jayendra Saraswathi Ayurveda college and hospital
Nazarathpet Chennai
Sri Jayendra Saraswathi Ayurveda college and hospital
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9791844576 |
| Fax |
|
| Email |
drsaravanan2k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrB Saravanan |
| Designation |
HOD & Proff |
| Affiliation |
|
| Address |
Department of Rasashastra and Bhaishjya Kalpana.
Sri Jayendra Saraswathi Ayurveda college and hospital
Nazarathpet Chennai
Department of Rasashastra and Bhaishjya Kalpana.
Sri Jayendra Saraswathi Ayurveda college and hospital
Nazhrathpettai Chennai
600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9791844576 |
| Fax |
|
| Email |
drsaravanan2k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Rasashastra and Bhaishjya Kalpana.
Sri Jayendra saraswathi Ayurveda medical college and hospital
Nazhrathpettai Chennai
600123
India |
|
|
Primary Sponsor
|
| Name |
Anagha Ajetrao |
| Address |
Sri Jayendra Sarawathi Ayurveda College and Hospital.Nazhrathpettai Chennai
600123
India |
| Type of Sponsor |
Other [Individual 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 |
| Anagha Dhanaraj Ajetrao |
Sri Jayendra Saraswathi Ayurveda Medical College and Hospital |
Department of Rasashastra and Bhaishjya kalpana.
Sri Jayendra Saraswathi Ayurveda college and hospital
Nazarathpet Chennai Tamilnadu
600123
Thiruvallur
TAMIL NADU |
09303054868
anaghaajetrao99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Females (18-40 yo) with Facial hair |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: keshnashaka lepa, Reference: sharangdhar samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 100(g), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: keshnashaka cream, Reference: sharangdhar samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 100(g), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients show features of facial hirsutism irrespective of the underlying cause. |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find long lasting and effective alternative for facial hair removal |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To modify Kesh-nashaka lepa to cream |
7 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
27/03/2026 |
| 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="0"
Months="0"
Days="7" |
|
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
|
This study aims to evaluate and compare the therapeutic effectiveness of Kesh-nashaka cream compared to Kesh-nashaka lepa. Keshnashaka Lepa is an ayurvedic mineral drug which is traditionally claimed to result in permanent hair removal, leaving the treated skin smooth, comparable to the scalp of a monk.This formulation consists of Shankha (conch shell powder), Hartala (orpiment), Manashila (realgar) and Sajjikshara (alkaline salt). These ingredients are mixed with water to prepare a paste (Lepa) and applied daily for seven days. As the preparation of the Lepa can be time-consuming and inconvenient for regular use, an attempt will be made to develop a cream-based formulation for improved ease of application and user compliance. Thus, this study is planned to study the effectiveness of Kesh-Nashaka Lepa modified into cream in the management of the removal of facial hair in women. |