| CTRI Number |
CTRI/2026/02/102681 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see how the herbal powders Sharpunkha and Rohitak, along with a herbal paste (Dhanyakadi Lepa), help in treating acne (pimples). |
|
Scientific Title of Study
|
EVALUATE THE ADJUVANT EFFECT OF SHARPUNKHA CHURNA AND ROHITAK CHURNA WITH DHANYAKADI LEPA ON YUVAN PIDAKA W.S.R. TO ACNE VULGARIS. |
| 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 Kanchan Shamkant Patil |
| Designation |
|
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL |
| Address |
Department of Kayachikitsa
SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon Igatpuri Nashik
Nashik MAHARASHTRA 422402 India |
| Phone |
9021763899 |
| Fax |
|
| Email |
kanchanspatil06@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ankush Gunjal |
| Designation |
Associate Professor |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL |
| Address |
Department of Kayachikitsa
SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon Igatpuri Nashik
Nashik MAHARASHTRA 422402 India |
| Phone |
7359117691 |
| Fax |
|
| Email |
dr.ankush30@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kanchan Shamkant Patil |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL |
| Address |
Department of Kayachikitsa SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon Igatpuri Nashik
Nashik MAHARASHTRA 422402 India |
| Phone |
9021763899 |
| Fax |
|
| Email |
kanchanspatil06@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Kanchan Patil |
| Address |
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK 422402 |
| 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 Kanchan Shamkant Patil |
SMBT AYURVED COLLEGE AND HOSPITAL |
Department of Kayachikitsa
SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon, Igatpuri, Nashik Nashik MAHARASHTRA |
09021763899
kanchanspatil06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT AYURVED COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: PIDAKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: SUSHRUT SAMHITA, Procedure details: MIX THE CHURNA WITH LUKEWARM WATER) (1) Medicine Name: DHANYAKADI LEPA, Reference: SUSHRUT SAMHITA, Route: Topical, Dosage Form: Lepa Churna, Dose: 0(NA), Frequency: od, Duration: 20 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ROHITAKA, Reference: BHAVPRAKASHA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: KOSHNAJALA), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHARPUNKHA , Reference: BHAVPRAKASHA SAMHITA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: KOSHNA JALA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
The diagnosed patient of Yuvan Pidaka according to
classical sign and symptoms.
Patient in age group of 18 to 30 years.
Patient were selected irrespective of Gender, religion, socio-economic status etc.
Acne on face, upper part of chest and back
Patients willing for trial. |
|
| ExclusionCriteria |
| Details |
Patients having age below 18 years and above 30 years
Patients having another chronic skin diseases Psoriasis, Vitiligo , Urticaria , Melasma
Patients already on other treatment of Yuvan Pidaka
Patients unwilling for trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
evaluate the therapeutic efficacy of Sharpunkha Churna and
Rohitak Churna as an adjuvant therapy with Dhanyakadi Lepa in the
management of Yuvan Pidaka by measuring symptomatic
improvement within 20 days. |
7th ,14th,20th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
09/03/2026 |
| 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="1" Months="6" 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 - NO
|
|
Brief Summary
|
A CLINICAL STUDY TO EVALUATE THE ADJUVANT EFFECT OF
SHARPUNKHA CHURNA AND ROHITAK CHURNA WITH DHANYAKADI
LEPA ON YUVAN PIDAKA W.S.R. TO ACNE VULGARIS. Intoduction Clear skin is important for confidence, especially in young people. Yuvan Pidika (acne) is a common facial skin problem in teenagers and can cause stress and low self-esteem. In Ayurveda, it is called Mukhadushika and happens due to imbalance of body factors, mainly related to blood and digestion. Ancient texts say it looks like small painful bumps on the face. Ayurveda believes that problems in the liver and spleen affect the blood and lead to acne. Treating these root causes with specific herbal medicines can help control and improve acne naturallyNull Hypothesis There is no significant difference in the reduction of symptoms in
patients of Yuvan Pidaka using the combination of Sharpunkha
Churna and Rohitak Churna with Dhanyakadi Lepa over 20 days. Alternate Hypothesis The combination of Sharpunkha Churna and Rohitak Churna with
Dhanyakadi Lepa significantly reduces the symptoms in patients of
Yuvan Pidaka over 20 days. |