| CTRI Number |
CTRI/2026/04/108859 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Trial To Evaluate The Efficacy Of Siddharthakadi Lepa And Yavadi Lepa In Yauvanpidika |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial To Evaluate The Efficacy Of Siddharthakadi
Lepa And Yavadi Lepa In Yauvanpidika w.s.r.t 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 |
Rashmi Ramesh Gabhane |
| Designation |
PG Scholar |
| Affiliation |
Shiva Trust Yashwantrao Chavhan Ayurvedic Medical College Chhatrapati Sambhajinagar Aurangabad |
| Address |
Shiva Trust Yashwantrao Chavhan Ayurvedic Medical College and Hospital Kaychikitsa Department Chhatrapati Sambhajinagar(Aurangabad)
Aurangabad
Maharashtra
431005
India
Aurangabad MAHARASHTRA 431005 India |
| Phone |
9146479077 |
| Fax |
|
| Email |
rashmigabhane38@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Arshadkhan Rasulkhan Pathan |
| Designation |
Associate Professor |
| Affiliation |
Shiva Trust Yashwantrao Chavhan Ayurvedic Medical College and Hospital |
| Address |
Shiva Trust Yashwantrao Chavhan Ayurvedic Medical College and Hospital Kaychikitsa Department Chhatrapati Sambhajinagar Aurangabad Maharashtra
Aurangabad MAHARASHTRA 431005 India |
| Phone |
9096577523 |
| Fax |
|
| Email |
arshupathan78@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Arshadkhan Rasulkhan Pathan |
| Designation |
Associate Professor |
| Affiliation |
Shiva Trust Yashwantrao Chavhan Ayurvedic Medical College and Hospital |
| Address |
Shiva Trust Yashwantrao Chavhan Ayurvedic Medical College and Hospital Kaychikitsa Department Chhatrapati Sambhajinagar Aurangabad Maharashtra
Aurangabad MAHARASHTRA 431005 India |
| Phone |
9096577523 |
| Fax |
|
| Email |
arshupathan78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital
Kaychikitsa Department Hospital Building 4th floor Nipani Bhalgaon Chhatrapati
Sambhajinagar (Aurangabad)
Aurangabad
MAHARASHTRA
431005
India
|
|
|
Primary Sponsor
|
| Name |
Shiva Trust Yashwantrao Chavhan Ayurvedic Medical College and Hospital |
| Address |
Nipani-Bhalgaon,near Videocon comp ltd, Beed Highway, Chhatrapati Sambhajinagar,(Aurangabad) Maharashtra 431005 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Rashmi Ramesh Gabhane |
Shiva Trust Yashwantrao Chavhan Ayurvedic Medical College and Hospital |
Shiva Trust Yashwantrao Chavhan Ayurvedic Medical College and Hospital Kaychikitsa Department Chhatrapati Sambhajinagar Aurangabad Maharashtra Aurangabad MAHARASHTRA |
91464 79077
rashmigabhane38@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Chakradatta , Procedure details: Preparation of Yavadi Lepa : The herbs are taken fresh or dried & powdered (churna).Mixed
with appropriate liquid media (Drava dravya)
Made into a paste (Kalka form).
Application – According to Aacharya Sharangdhar Varnya lepa is used in all types
of kshudrarogas.
Direction - Pratilom gati.
Duration – Lepa are usually kept till drying stage; over-drying is avoided as it
causes increase of Vāta.)
| | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bharat Bhaisajya Ratnakar , Procedure details: Preparation of Siddharthakadi Lepa :The herbs are taken fresh or dried & powdered (churna).Mixed
with appropriate liquid media (Drava dravya)
Made into a paste (Kalka form).
Application – According to Aacharya Sharangdhar Varnya lepa is used in all types
of kshudrarogas.
Direction - Pratilom gati.
Duration – Lepa are usually kept till drying stage; over-drying is avoided as it
causes increase of Vāta.)
|
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Minimum 62 patients will be included in the study.
Age Group : 15 to 30 years.
Classical signs and symptoms of Yauvanpidika as mentioned in text like Shalmali thorns will be selected for study.Patients will be selected randomly from OPD and IPD irrespective of sex, religion, age etc.
|
|
| ExclusionCriteria |
| Details |
Patients having acne other than face( Shoulder, Neck, Abdomen)etc.
Patients having other types of Kshudrarogas and Kushtharog.
Pidika is produced due to any allergy.
Patients suffering from DM, HTN, Autoimmune disorders, HIV, Immunosuppressive drugs and any other major illness.
Endocrinal disease excluded. Pregnant and lactating women will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Siddharthakadi Lepa And Yavadi Lepa applied twice a day for 28 days in adults of age group of 15 - 30 years in Yauvanpidika (Acne Vulgaris) |
Follow-up on
7th, 14th, 21st, 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the disease Yauvanpidika with reference to Ayurvedic perspective.
2. To evaluate the disease Acne Vulgaris with Modern perspective.
3. To evaluate the ingredients of Siddharthakadi Lepa And Yavadi Lepa.
4. To evaluate the mode of action of Siddharthakadi Lepa And Yavadi Lepa.
5. To evaluate the efficacy of Siddharthakadi Lepa And Yavadi Lepa. |
Follow-up on
7th,14th,21st,28th day |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
15/05/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Today’s lifestyle, pollution, irregular diet are directly affecting skin .Face is the most important and beautiful organ. It is affected by certain anomalies of the adolescent age e.g. 15 – 30 years. All people remain more conscious about the beauty of their face in general and youngsters in particular. Yauvanpidika disfigures the face in this age group especially. In allopathy practice mainly Antibiotics , surgery or hormonal therapy are the only options. These are having hazardous effects or are very costly. Hence to have comparatively safer and cost effective natural herbs medicine is the need of the era. The drug can reverse the condition which has properties of kapha-vatashamak and raktashodhak and can be used for a long time without any harm. Herbal formulations, SIDDHARTHAKADI LEPA and YAVADI LEPA for external application were selected in the present study.
In the classical text of Sushrut samhita kshudrarogas are mentioned and Mukhadushika is one of them. It states that Yauvanpidika is a vyadhi avastha where the vitiation of kapha , vata dosha along with rakta dhatu dusti results in eruption of shalmali kantak sadrush pidaka. The Causes of raktaprokop are nidan of Mukhadushika, such as krodha, shoka, bhaya, ayasa, vidagdha ahara sevana, maithuna, intake of excess of katu rasa, amla rasa, lavana rasa, tikshana, ushna, laghu, vidahi ahara, excess, intake of dadhi, takra, sura etc. |