| CTRI Number |
CTRI/2025/12/098975 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
clinical study to evaluate the efficacy of mukhadushikahar lepa and clindamycin in the management of mukhadushika with special reference to acne vulgaris |
|
Scientific Title of Study
|
Randomised controlled clinical study to evaluate the efficacy of mukhadushikahar lepa and clindamycin in the management of mukhadushika with special reference 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 Jyoti B Choure |
| Designation |
Associate professor |
| Affiliation |
LRPAMCH, ISLAMPUR |
| Address |
loknete rajarambapu patil ayurvedic medical college and hospital, post graduate institute and research centre, urun-islampur , dist. sangli
loknete rajarambapu patil ayurvedic medical college and hospital, post graduate institute and research centre, urun-islampur , dist. sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9423471756 |
| Fax |
|
| Email |
jyotichoure23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti B Choure |
| Designation |
Associate professor |
| Affiliation |
LRPAMCH, ISLAMPUR |
| Address |
loknete rajarambapu patil ayurvedic medical college and hospital, post graduate institute and research centre, urun-islampur , dist. sangli
loknete rajarambapu patil ayurvedic medical college and hospital, post graduate institute and research centre, urun-islampur , dist. sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9423471756 |
| Fax |
|
| Email |
jyotichoure23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti B Choure |
| Designation |
Associate professor |
| Affiliation |
LRPAMCH, ISLAMPUR |
| Address |
loknete rajarambapu patil ayurvedic medical college and hospital, post graduate institute and research centre, urun-islampur , dist. sangli
loknete rajarambapu patil ayurvedic medical college and hospital, post graduate institute and research centre, urun-islampur , dist. sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9423471756 |
| Fax |
|
| Email |
jyotichoure23@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhimanyu Patil |
| Address |
loknete rajarambapu ayurvedic medical college and hospital ,post graduate institute and research centre, urun-islampur415409 dist. sangli |
| 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 |
| Dr Jyoti choure |
LRP ayurvedic medical college and hospital pg institute and research centre urun islampur -415409 |
swastha vritta department room no 7
Sangli
MAHARASHTRA |
7709677061
shubhasn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicalCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
acne vulgaris |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | clindamycin 1% ointment | Clindamycin stops bacteria from making proteins by attaching to the 50S part of their ribosome. It also shows anti-inflammatory actions that add to its usefulness, especially in acne treatment.It also possesses anti-inflammatory properties that contribute to its clinical efficacy, especially in conditions like acne. |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Participants of either sex between the Age group of 13–30 years.
Willingness to give informed consent.
Voluntarily desires to take treatment.
|
|
| ExclusionCriteria |
| Details |
Severe cases of acne vulgaris
Known hypersensitivity to trial or control drug.
Pregnant or lactating women.
Systemic illness like Diabetes Mellitus and Thyroid Disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the clinical efficacy of MukhdushikaharLepa in the management of Tarunyapidika (Acne Vulgaris).
To compare the clinical efficacy of Mukhdushikahar Lepa and local application of Clindamycin in the management of Mukhadushika (AcnE Vulgaris).
|
alternate 30 days (once a day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety & tolerability of both interventions.
To evaluate recurrence rate in post-treatment.
|
alternate 30 days (once a day) |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
22/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
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
|
Patients will be well informed and consent will be taken prior to study. The study will be conducted on 45 patients each for trial and control group. Patients showing the signs and symptoms of mukhadushika will be choosen randomly divided for both the groups and mukhadushikahar lepa and clindamycin ointment will be applied to respective groups once a day for alternative 30 days. Followup will be on 16th and 31st day for assessing the reduction in signs and symptoms . One follow up will be on 60th day to check for reoccurence of signs and symptoms. Conclusions will be drawn on the basis of proper statistical methods. |