| CTRI Number |
CTRI/2025/03/083606 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [High frequency cosmetic procedure] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of acne with High-Frequency treatment and Lodhradi gel |
|
Scientific Title of Study
|
A comparative clinical study for efficacy of Lodhradi gel and High-Frequency treatment in management of yuvanpidika |
| 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 Shreya Arya |
| Designation |
M.Sc. (Ayu.) Scholar |
| Affiliation |
National Institute of Ayurveda, jaipur |
| Address |
Department of Saundarya Ayurveda
National Institute of Ayurveda
Deemed to be University
Near Jorawar Singh Gate Amer road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9015346675 |
| Fax |
|
| Email |
aryashreya547@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudipt Kumar Rath |
| Designation |
HOD and Professor of Department of Dravyaguna, Dean M.Sc. Interdisciplinary |
| Affiliation |
National Institute of Ayurveda Deemed to be university, Jaipur |
| Address |
Department of Dravyaguna
National Institute of Ayurveda
Deemed to be university Near Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9828376668 |
| Fax |
|
| Email |
sudipt@nia.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagriti Sharma |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda Deemed to be university, Jaipur |
| Address |
Department of Saundarya Ayurveda
National Institute of Ayurveda
Deemed to be university
Near Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461162206 |
| Fax |
|
| Email |
drjagritisharma573@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda
Deemed to be university
Jaipur
Rajasthan
India
302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Deemed to be university, Jaipur |
| Address |
Near Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan-302002 |
| Type of Sponsor |
Other [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 Shreya Arya |
National Institute of Ayurveda, Jaipur |
OPD Number- 19 National Institute of Ayurveda Near Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan-302002
Jaipur
RAJASTHAN |
9015346675
aryashreya547@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Ayurveda, jaipur |
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: Shusruta Samhita, Chikitsa Sthana 20/38), Procedure details: Topical application Once a day in morning for 1
Month, Apply uniformly on face in Sufficient quantity)
(1) Medicine Name: Lodhradi gel, Reference: Lodhradi Lepa (Shusruta Samhita, Chikitsa Sthana 20/38), Route: Topical, Dosage Form: Not Applicable, Dose: 2(g), Frequency: od, Duration: 1 Months | | 2 | Intervention Arm | Procedure | - | High Frequency | (Procedure Reference: Leonie Frommherz, Markus Reinholz, Anne Gürtler, Pia-Charlotte Stadler, Till Kaemmerer, Lars French, and Benjamin M. Clanner-Engelshofen High-frequency devices effect in vitro: promissing approach in the treatment of acne vulgaris? National Libraray Of Medicine , Procedure details: High Frequency treatment will be given for 8 min at 50Hz once a week for 1 month.)
| | 3 | Comparator Arm (Non Ayurveda) | | - | Lodhradi gel followed by High frequency | High frequency treatment will be given using Lodhradi gel for 8 min at 50Hz once a week for 1 month. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Yuvanpidika age groups 18-35 years of either gender.
Patients having cardinal symptoms of the disease like Pidika on face including Ruja, Daha, Paka, Srava of Yuvanpidika mentioned in Ayurveda and modern literature features of acne vulgaris like Papules, Pustules, Black & White head, Itching, Redness & Inflammation around eruption.
Distribution of Yuvanpidika on Forehead, Cheeks, Nose & Chin. |
|
| ExclusionCriteria |
| Details |
Diagnosed Patient with Carcinoma, Burns, Herpes, Eczema, Psoriasis, Measles, Chickenpox, Leukoderma and Leprosy.
Patients with known case of common systemic diseases like T.B. Diabetes, AIDS, and Leprosy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Total Lesion Count -Reduction in the total number of Acne lesions Pidika(inflammatory and non-inflammatory ) from baseline to specified follow up period. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Severity of Acne: Assessed using validated scales for classical symptoms and IGA (Investigator’s global assessment) scale
Adverse Events-Monitoring and documenting any side effects or complications arising from
treatment.
Change in Skin Oiliness: Measuring oiliness of skin as changes in sebum production as a secondary effect of treatment
|
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/03/2025 |
| Date of Study Completion (India) |
30/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In Ayurvedic literature, the use of Lodhradi Lepa (Shusruta Samhita, Chikitsa Sthana 20/38) is mentioned for the treatment of Yuvanpidika (acne vulgaris). However, in today’s lifestyle, the process of daily application, waiting for it to partially dry, and then washing it off can be time consuming and somewhat inconvenient. Transforming the same formulation into a gel would provide a more convenient and user-friendly alternative.High-Frequency treatment demonstrated a microbicidal effect on skin flora and pathogens in vitro with a significant decrease in bacterial and fungal counts after a short treatment period. RESEARCH QUESTION: Whether there is any difference in clinical efficacy of Lodhradi Gel and High-Frequency treatment in management of Yuvanpidika? STUDY DESIGN- the study consists of 3 groups with 10 patients in each group. Group A - We are giving Lodhradi gel as topical application once in a day for 1 month. Group B - We are giving High-Frequency treatment to patients for 8 minutes once a week for 1 month. Group C - We are giving Lodhradi gel + High-Frequency treatment for 8 minutes once a week for 1 month ASSESMENT: Assessment will be done on basis of Scoring pattern for symptoms of Yuvanpidika and IGA scale for acne vulgaris.
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