| CTRI Number |
CTRI/2025/08/093349 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
PUBLIC TITLE OF STUDY TO EVALUATE THE EFFECT OF ARJUNA CHURN FACE MASK WITH SARIVA CHURNA INTERNALLY BY MOUTH IN THE MANAGEMENT OF ACNE VULGARIS |
|
Scientific Title of Study
|
RANDOMISED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF GAVYA ARJUNA LEPA WITH SARIVA CHURNA INTERNALLY IN THE MANAGEMENT OF MUKHDUSHIKA (YUVAN PIDIKA)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 Nikita hanmatrao pujalwar |
| Designation |
Pg scholar |
| Affiliation |
OPD no.17 kaychikitsa department Yashwant ayurvedic college PGT and RC kodoli |
| Address |
Yashwant ayurvedic college PGT and RC kodoli tal.panhala dist- kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8329731841 |
| Fax |
|
| Email |
nikitapujalwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryakiran parashuram wagh |
| Designation |
Professor |
| Affiliation |
OPD no 17 kaychikitsa department Yashwant ayurvedic college PGT and RC kodoli |
| Address |
Yashwant ayurvedic college PGT and RC kodoli tal.panhala dist-kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822846910 |
| Fax |
|
| Email |
suryakirran_wagh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita hanmatrao pujalwar |
| Designation |
PG scholar |
| Affiliation |
OPD no 17 kaychikitsa department Yashwant ayurvedic college PGT and RC kodoli |
| Address |
Yashwant ayurvedic college PGT and RC kodoli tal.panhala dist- kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8329731841 |
| Fax |
|
| Email |
nikitapujalwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| S G phytopharma Address B-53D/21 MIDC Gokul shirgaon, S G phytopharma pharmaceutical ltd kolhapur 416237 |
|
|
Primary Sponsor
|
| Name |
Dr Nikita hanmatrao pujalwar |
| Address |
Yashwant ayurvedic college post graduate training and research centre kodoli tal.panhala dist-kolhapur |
| 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 Nikita hanmatrao pujalwar |
Yashwant dharmarth rugnalay kodoli |
Casualty and opd no 17 kaychikitsa department second floor Yashwant ayurvedic college post graduate training and research centre kodoli tal panhala dist-kolhapur
Kolhapur
MAHARASHTRA |
8329731841
nikitapujalwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Yashwant ayurvedic College PGT and RC kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), (2) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: YUVAN, (3) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: YUVAN, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gavya arjuna lepa , Reference: Yogratnakar samhita (kshudraroga chikista), Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -gavya arjuna churna mix with godugdh as per need and applied on face for 30min | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sariva churna, Reference: Dhanvantari nighantu (guduchyadi varg ), Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -jal), Additional Information: -2gm sariva churna with normal water bid |
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
Patients with sign and symptoms of mukhdushika |
|
| ExclusionCriteria |
| Details |
Known case of hypersensitive skin conditions, patients having another chronic skin disease, patients having pidikas of other kshudraroga, visarpa,prameha,shitpitta,masurika |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of gavya arjuna lepa with sariva churna internally in mukhdushika w.s.r.acne vulgaris |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the number of pitikas on face, To study the raktima and pak of pitika,
To study bahiparimarjan chikitsa and lepa kalpna in various literature,
To study mukhdushika vyadhi in detail |
30 days |
|
|
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
|
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="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
|
My title is "RANDOMISED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF GAVYA ARJUNA LEPA WITH SARIVA CHURNA INTERNALLY IN THE MANAGEMENT OF MUKHDUSHIKA (YUVAN PIDIKA) W.S.R.TO ACNE VULGARIS" included the patient with sign and symptoms of mukhdushika vyadhi pitika,raktima,pak,shool,dah . Treatment given gavya arjuna lepa for 30min for 30days and sariva churna twice in day for 30days internally in mukhdushika vyadhi. To study the change in sign and symptoms of mukhdushika vyadhi. |