| CTRI Number |
CTRI/2025/11/097641 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of Siddharthak gel in the management of dandruff (Darunak) |
|
Scientific Title of Study
|
Pharmaceutico–analytical and Clinical study of Siddharthak gel in the management of Darunak with special reference to dandruff |
| 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 Mrunali Ajit Patil |
| Designation |
PhD Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College, Post Graduate and Research Center, Ashta |
| Address |
PhD Scholar
Department of Rasashastra and BK,
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center, Ashta
Tal-Walwa Dist- Sangli - 416 301, Maharashtra, India.
Sangli
MAHARASHTRA
416301
India |
| Phone |
9421987355 |
| Fax |
|
| Email |
mrunali.p16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Prabhakar Inamdar |
| Designation |
Guide, HOD and Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College, Post Graduate and Research Center, Ashta |
| Address |
HOD & Professor,
Department of Rasashastra and BK,
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center, Ashta
Tal-Walwa Dist- Sangli - 416 301, Maharashtra, India.
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422409112 |
| Fax |
|
| Email |
drimp73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrunali Ajit Patil |
| Designation |
PhD Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College, Post Graduate and Research Center, Ashta |
| Address |
PhD Scholar
Department of Rasashastra and BK,
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center, Ashta
Tal-Walwa Dist- Sangli - 416 301, Maharashtra, India.
Sangli
MAHARASHTRA
416301
India |
| Phone |
9421987355 |
| Fax |
|
| Email |
mrunali.p16@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Mrunali Ajit Patil |
| Address |
PhD Scholar,
Department of Rasashastra and BK,
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center, Ashta
Tal-Walwa Dist- Sangli - 416 301, 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 Mrunali Ajit Patil |
Hon. Shri Annasaheb Dange Ayurved Medical College & Hospital, Ashta |
Kayachikitsa OPD,
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center, Ashta
Tal-Walwa Dist- Sangli - 416 301, Maharashtra, India.
Sangli
MAHARASHTRA |
9421987355
mrunali.p16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, ADAMC, Ashta |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L21||Seborrheic dermatitis. Ayurveda Condition: DARUNAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Siddharthak Gel, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: The dosage form selected as ‘Lepa Churna’ is chosen only because the CTRI dropdown does not provide an option for Gel or Lepa. The actual formulation is a modern topical Gel prepared using Siddharthak Choorna (Musta, Madanphala, Triphala, Karanja, Amlatas, Indrayava, Darvi, Saptaparna) incorporated into a modern gel base. The drug is applied externally on the scalp in a dose of 10 g on alternate days. Frequency is marked as OD as per available CTRI options and clarified here. Duration of therapy is 14 days with a total of 7 applications. Bhaishajya Kala is not applicable for topical use; ‘Muhur Muhu’ is selected only to complete the mandatory field. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
18-50 years age group participants irrespective of sex, religion, socio-economic and marital status suffering from Darunak |
|
| ExclusionCriteria |
| Details |
Participants suffering from severe seborrheic dermatitis, psoriasis of scalp,
eczema of scalp, participants of immune compromised conditions, known case of
Diabetes mellitus and suffering from systemic infections will be excluded from
the study. Participants taking other treatment modalities will also be excluded
from study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in signs and symptoms of Darunak (dandruff), including:
Kandu (itching)
Rukshata (dryness of scalp)
Twaksputana (scaling / flaking)
Keshachyuti (hair fall)
Each parameter graded on 0–3 scale (0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe). Mean percentage reduction in total symptom score will be evaluated. |
Day 0 (Baseline), Day 6, Day 10, and Day 17 (Post-treatment). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Trichoscopic Evaluation:
Reduction in dandruff grade using trichoscopic scoring (0–5 scale) assessing adherent scales and scalp erythema. |
Trichoscopic assessment: Day 0 (Baseline) and Day 17 (Post-treatment) |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
18/12/2025 |
| 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="0"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mrunali.p16@gmail.com].
- For how long will this data be available start date provided 17-11-2027 and end date provided 16-11-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is designed to evaluate the pharmaceutico analytical and clinical efficacy of Siddharthak Gel, a novel polyherbal topical formulation, in the management of Darunak with special reference to dandruff. Siddharthak Gel is prepared from Siddharthak Choorna containing Musta, Madanphala, Triphala, Karanja, Aaragvadh, Indrayava, Darvi, and Saptaparna in a carbopol based gel form. The objective is to assess its effect on cardinal symptoms such as Kandu, Rukshata, Twaksputana, and Keshachyuti, as well as to observe improvement through trichoscopic evaluation. The trial is a single arm, open label, prospective clinical study involving 140 participants aged 18 to 50 years. The formulation will be applied topically on the scalp, 10 g per dose, once on alternate days for 14 days. The study aims to establish the efficacy and safety of Siddharthak Gel as a standardized and patient friendly topical formulation for dandruff management based on Ayurvedic principles of Darunak Chikitsa. |