| CTRI Number |
CTRI/2025/09/094994 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of acne through tarunyapidikahar lepa. |
|
Scientific Title of Study
|
Randomised clinical trial (RCT) on the effect of tarunyapidikahar lepa in management of tarunyapidika (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 Pooja Meena |
| Designation |
P.G. Scholar |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Associated Pt. PLRD Vaidya Chikitsalaya |
| Address |
Kaya Chikitsa Department, Hospital Block, Opp. Dharpa Power House, Khurja, Bulandshahr, UP, India, 203131
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7983492838 |
| Fax |
|
| Email |
drsyadav39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Gupta |
| Designation |
Associate Professor |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Associated Pt. PLRD Vaidya Chikitsalaya |
| Address |
Kaya Chikitsa Department, Hospital Block, Opp. Dharpa Power House, Khurja, Bulandshahr, UP, India, 203131
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8004675658 |
| Fax |
|
| Email |
vandanag54321@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Meena |
| Designation |
P.G. Scholar |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Associated Pt. PLRD Vaidya Chikitsalaya |
| Address |
Kaya Chikitsa Department, Hospital Block, Opp. Dharpa Power House, Khurja, Bulandshahr, UP, India, 203131
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7983492838 |
| Fax |
|
| Email |
drsyadav39@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Pooja Meena, Kaya Chikitsa Department, Hospital Block, Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Associated Pt. PLRD Vaidya Chikitsalaya, Opp. Dharpa Power House, Khurja, Bulandshahr, UP, India, 203131 |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Meena |
| Address |
Kaya Chikitsa Department, Hospital Block, Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Associated Pt. PLRD Vaidya Chikitsalaya, Opp. Dharpa Power House, Khurja, Bulandshahr, UP, India, 203131 |
| 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 Pooja Meena |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Associated Pt. PLRD Vaidya Chikitsalaya |
OPD and IPD, Kaya Chikitsa Department, Hospital Block, Opp. Dharpa Power House, Khurja, Bulandshahr, UP, India, 203131
Bulandshahar
UTTAR PRADESH |
7983492838
drsyadav39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya, Khurja, Bulandshahr, UP |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Clindamycin, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tarunyapidikahar Lepa, Reference: Lepa Bhaishajya Ratnavali (Kshudrarogadhikara 60/38), Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients with type of acne lesions like G0, G1, G2, and G3 (limited to face) |
|
| ExclusionCriteria |
| Details |
Age below 14 years and above 35 years.
Complicated cases like cyst abscess etc.
Acne with systemic involvement. (Eg: Acne fulminanes, SAPHO (Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis), PAPA (Pyogenic, Arthritis, Pyoderma gangrenosum, Acne) syndromes)
Lesion present other than face.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome of the therapies will be compared before and after the treatment on the basis of self formulated scoring scale to signs and symptoms in subjective and objective parameters.
Relief in the following observing parameter-
Pain- Ruja
Itching -kandu
Number of Acne lesion -sankhaya
Oiliness of face
|
0th day, 30th day and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in quality of life
Reduction in psychological stress, self-consciousness, and social embarrassment due to acne. |
60th 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
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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="0"
Months="3"
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
|
Considering the principles of Ayurveda, the growing demand for cosmetology among the younger generation, and the increasing prevalence of common skin ailments such as acne, this study is needed to explore safe, effective, and holistic management approaches. Protocol for Study- 40 patients of Acne vulgaris will be randomly selected and will be divided into two groups. Group A- 20 no. of patients will be given trial drug i.e. tarunyapidikahar lepa. GroupB- 20 no. of patients will be given control drug i.e. clindamycin phosphate gel. Trial period- The treatment will be applied for 2 months. Oberservation period- 2 follow up will be done in each 30th day. |