| CTRI Number |
CTRI/2025/02/080606 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Management] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic trial for the treatment of acne vulgaris |
|
Scientific Title of Study
|
A Comparative study to evaluate the efficacy of kustumburuadi lepa and vachadi lepa in the management of yuvanapidaka ( Acne vulgaris)(Randomized Control Trial) |
| 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 Monika |
| Designation |
PG Scholar department of swasthavritta |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No 222 PG department of swasthavritta Ch Brahm Prakash Ayurved Charak Sansthan khera Dabar Najafgarh New Delhi 110073
South West
DELHI
110073
India |
| Phone |
9540744553 |
| Fax |
|
| Email |
monika8470070@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Unnikrishnan S |
| Designation |
HOD department of swasthavritta |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 232 PG department of swasthavritta Ch Brahm Prakash Ayurved Charak Sansthan khera Dabar Najafgarh New Delhi 110073
South West
DELHI
110073
India |
| Phone |
9540265445 |
| Fax |
|
| Email |
drunnikrishnans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Unnikrishnan S |
| Designation |
HOD department of swasthavritta |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 232 PG department of swasthavritta Ch Brahm Prakash Ayurved Charak Sansthan khera Dabar Najafgarh New Delhi 110073
South West
DELHI
110073
India |
| Phone |
9540265445 |
| Fax |
|
| Email |
drunnikrishnans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi-110073 India |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar Najafgarh New Delhi 110073 |
| 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 Monika |
Ch Brahm Prakash Ayurved Charak Sansthan |
OPD no 20 PG department of Swasthavritta Hospital block Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh 110073 south west DELHI
South West
DELHI |
9540744553
monika8470070@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhavprakash, Procedure details: firstly wash face with plain water. then apply lepa paste in opposite direction of hair roots. After lepa start drying wash with plain water.)
(1) Medicine Name: Vacha Lodhra Sarshapa Saindhava, Reference: Sushruta Samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 30 Days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhavprakash, Procedure details: firstly wash face with plain water. then apply lepa paste in opposite direction of hair roots. After lepa start drying wash with plain water.)
(1) Medicine Name: Kustumburu Vacha Lodhra Kushtha, Reference: Sushruta Samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of age 18 to 30.
2) Patient having associated symptoms like blackhead, pustules.
3) Patient of either sex will be included.
4) Subject having cardinal sign and symptoms of yuvanapidaka on face having symptoms like ruja , shotha , srava, vaivarnaya.
5) Patient willing to participate with written consent.
|
|
| ExclusionCriteria |
| Details |
1) Patient of hypersensitivity.
2) Patient having any infectious disease and any skin disease like Scabies, Psoriasis, Eczema etc.
3) Immunodeficiency state
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| : Improvement in grade of severity according to CASS( Comprehensive acne severity scale) |
0,15th, 30th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective parameters of Yuvanapidaka .
|
16th, 31st day |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
01/03/2025 |
| 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="0"
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
|
This study is Randomized control trial to compare the effect of kustumburuadi lepa and vachadi lepa in management of yuvanapidaka (Acne vulgaris). In one group application of kustumburuadi lepa for 30 days on alternate days and assessment periods will be 0,15 ,30th day. In another group application of vachadi lepa on alternate day for 30 days and assessment will be 0, 15, 30th day. This will be conducted in Ch. brahm prakash ayurved charak sansthan with outcome: Effect of kustumburuadi lepa is better than vachadi lepa in the management of yuvanapidaka in improving CASS scale and subjective parameter.
|