| CTRI Number |
CTRI/2024/01/061724 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare ayurvedic medicine application in acne vulgaris |
|
Scientific Title of Study
|
A Randomised Control Clinical Study To Compare The Efficacy Of Jatiphaladi Lepa With Lodhradi Lepa In Management Of Mukhdushika (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 Kiran Avdhut Chaudhari |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Dept of Kayachikitsa Tilak Ayurved Mahavidyalaya Rasta peth
Pune
MAHARASHTRA
411011
India |
| Phone |
7709289080 |
| Fax |
|
| Email |
kiranchaudharin556@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadanand vitthal Deshpande |
| Designation |
Professor and HOD |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Dept of Kayachikitsa Tilak Ayurved Mahavidyalaya Rasta peth
Pune
MAHARASHTRA
411011
India |
| Phone |
996007113 |
| Fax |
|
| Email |
drsvdeshpande61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadanand vitthal Deshpande |
| Designation |
Professor and HOD |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Dept of Kayachikitsa Tilak Ayurved Mahavidyalaya Rasta peth
MAHARASHTRA
411011
India |
| Phone |
996007113 |
| Fax |
|
| Email |
drsvdeshpande61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital |
|
|
Primary Sponsor
|
| Name |
Tilak ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital |
| Address |
Dept of Kayachikitsa rasta peth |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kiran Avdhut Chaudhari |
Tilak ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital |
Dept of Kayachikitsa opd no 5 6 13 rasta peth
Pune
MAHARASHTRA |
7709289080
kiranchaudharin556@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jatiphaladi lepa, Reference: Yogratnakar , Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Lodharadi lepa , Reference: Yogratnakar , Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Chronicity less than 2 years |
|
| ExclusionCriteria |
| Details |
Pidika other than face
Using regular cosmetics |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Itching pain discharge burning pidika |
0, 7 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comedones |
21 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
31/01/2024 |
| 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 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
|
Acne is the most common skin disorder found in adolescent age group around the world. Current treatment of Acne in Modern medicine is antibiotics, Vit A, Corticosteroids, Ultraviolet radiation and lotion for the external application. Generally patients Discontinue medicine as fast result is not obtained. Resistance of drug, recurrence of Disease and shifting from one pathy to other are the main hurdles in acne management. As the young patients are beauty conscious, use of any type of cosmetics, various beauty Products, no of face wash and frequent visits to beauty parlour are common in Acne Management. These self medication make this disease chronic and though it is Kshudraroga, it becomes very difficult to treat. For this reason we have decided to treat The patient externally
- Jatiphaladi Lepa specially made for Acne Vulgaris, this lepa supresses the Acne Vulgaris, "Black Spot" "Vyang" and Nilika.It is very good for skin.
- It connects very effective drugs which plays important role for the beauty of skin. The content of Jatiphaladi Lepam make the skin healthy and glorious.
- Jatiphaladi Lepa acts as vranshodak and Ropan to skin, due to presence of jatiphala in this lepa. Extensive studies have indicated wound healing inflammation modifying action of this plant. The inflammation response Fibroblast, Proliferation, Collagenisation and Epithelisation were better with jatiphala. |