| CTRI Number |
CTRI/2025/03/083375 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [prakriti based aahar] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study on management of Yauvanpidika (Acne) through Yavadi lepa and Yavadi lepa along with Prakriti based Diet |
|
Scientific Title of Study
|
Randomized comparative study to evaluate the effect of Yavadi Lepa with and without Prakriti based Aahar in management of Yauvanpidika |
| 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 Komal Sharma |
| Designation |
MD Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
Pg Department of Kriya Sharir Madan Mohan Malviya Government Ayurved College Rada Ji Choraha Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8302167909 |
| Fax |
|
| Email |
iamkomalsharm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ashok Kumar Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
Pg Department Of Kriya Sharir Madan Mohan Malviya Government Ayurved College Rada Ji Choraha Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413205904 |
| Fax |
|
| Email |
sharmadrak06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Ashok Kumar Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
Pg Department Of Kriya Sharir Madan Mohan Malviya Government Ayurved College Rada Ji Choraha Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413205904 |
| Fax |
|
| Email |
sharmadrak06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College Rada Ji Choraha Udaipur Rajasthan India 313001 |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College |
| Address |
Madan Mohan Malviya Government Ayurved College Rada Ji Choraha Udaipur Rajasthan India 313001 |
| Type of Sponsor |
Government 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 Komal Sharma |
MMMGAC Affiliated Hospitals |
OPD room number 2 Govt. Ayurved Hospital (Rajved Premshankar Sharma)Near Rada Ji Chowk Udaipur - 313001 Rajasthan India
Udaipur
RAJASTHAN |
8302167909
iamkomalsharm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MMMGAC |
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 | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhara Samhita Uttarkhanda , Procedure details: The powder of mentioned ingredients were sieved
by No.120 sieve separately. The fine powder of each ingredient in mentioned quantity was taken & mixed homogenously. Prepared Lepa Churna was stored in airtight container.)
(1) Medicine Name: Yavadi lepa, Reference: Chakradutta, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Duration: 45 Days | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Prakriti based Aahar, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. patient age should between 18 years to 30 years
2. patient who willingly participate in the trail
3. patient who have resembling with yauvanpidika symptoms as given in classic text
4. patient of both gender will be taken |
|
| ExclusionCriteria |
| Details |
1. Volunteers having age below 18 years and above 30 years will be excluded.
2. Volunteers with systemic disorders like Thyroid dysfunction, Amlapitta, Shitpitta.
3. Pregnant and lactating women will be excluded.
4. Person who is not willing to participate in the study.
5. Person having other skin disorders or drug dependency.
6. Person with major medical or surgical illness will be excluded from study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Yavadi lepa and Yavadi lepa along with Aahar in different Prakriti patient of Yauvanpidika. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare lepa with and without prakriti based aahar in management of yauvanpidika |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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="7"
Days="15" |
|
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
|
This study the 60 clinically diagnosed patients of Yauvanpidika / acne vulgaris will be registered from associated hospitals by M.M.M Govt. Ayurveda Collage, Udaipur. and from various medical camps.The patients will be divided into two group;1) Group A-Yavadi lepa2) Group B -Yavadi lepa along with prakriti based aahar.This study Aims to check to compare the effect of Yavadi lepa and Yavadi lepa along with Aahar in different Prakriti patient of Yauvanpidika. |