A comparative clinical study for efficacy of Lodhradi gel and High-Frequency treatment in management of yuvanpidika
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 Yuvanpidikaand IGA scale for acne vulgaris.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: 1 month
Secondary Outcomes
- 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)
Investigators
Dr Shreya Arya
National Institute of Ayurveda, jaipur