This Clinical Trial is intented to compare the efficacy of Mukhadushikahara Acne Patch with Mukhadushikahara lepa along with Triphaladi Kashaya intenally in the management of Acne Vulgaris.

Phase 2/3

Recruiting

• Conditions: Acne vulgaris. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), (2) ICD-10 Condition: L449||Papulosquamous disorder, unspecified. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), (3) ICD-10 Condition: L449||Papulosquamous disorder, unspecified. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), (4) ICD-10 Condition: L55-L59||Radiation-related disorders of the skin and subcutaneous tissue. Ayurveda Condition: KSHUDRAROGAH yuvanpidika,

• Registration Number: CTRI/2023/09/057620
• Lead Sponsor: Institute of Teaching and Research in Ayurveda, Jamnagar

Brief Summary

An open labelled, randomized, comparative, parallel, two arm clinical trial has been designed for comparison of efficacy of topical application of *Mukhadushikahara* Acne Patch and *Mukhadushikahara Lepa* along with Triphaladi Kashaya as internal medicine in the management of *Mukhadushika* (Acne Vulgaris) for 30 days. There will be two groups with sample size 50 in either group. Primary outcome will be relief in the Chief Complaints of Mukhadushika (Acne Vulgaris) viz. Number of Pidaka (papules), Ruja (pain), Ghana pidaka (thickness), Daha (burning sensation), Srava (discharge), Medogarbha (filled with sebum). Secondary outcome will be Relief in the Associated Complaints of Mukhadushika (Acne Vulgaris) viz. Shotha (Inflammation), Kandu (Itching), Snigdha Tvaka (Oily skin), Vrana Vastu (Scar), Vaivarnya (Discolouration), Shotha (Inflammation).

In group A - *Mukhadushikahara* Acne Patch (external) along with Triphaladi Kashaya as internal medicine will be given for 30 days.

In group  B- *Mukhadushikahara* *Lepa* along with Triphaladi Kashaya as internal medicine will be given for 30 days.

**Materials:**

1.      Patients of *Mukhadushika* (Acne vulgaris).

2.      Trial drugs – *Triphaladi Kashaya, Mukhadushikahara lepa*, *Mukhadushikahara* Acne Patch.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-11
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients having classical signs and symptoms of Mukhadushika (Acne Vulgaris) on Face.

Exclusion Criteria

• The age of patient less than 18 years and more than 30 years.
• Patients having Mukhadushika on other parts of body.
• Known cases of any systemic diseases like Diabetes, Cardiac diseases, Renal disorder, Hypothyroidism etc.
• or any viral infection.
• Known cases of Carcinogenic condition of sebaceous gland.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in the Chief Complaints of Mukhadushika (Acne Vulgaris)-Number of Pidaka (papules), Ruja (pain), Ghana pidaka (thickness), Daha (burning sensation), Srava (discharge), Medogarbha (filled with sebum) will be assessed. Number of lesions (papules/ pustules / nodular) & Area cover will be measured before and after treatment.	Baseline, 7th Day. 15th Day, 21st Day, 30th Day
Severity of Acne Vulgaris will be assessed using (IGAS scale) before and after treatment.	Baseline, 7th Day. 15th Day, 21st Day, 30th Day

Secondary Outcome Measures

Name	Time	Method
Relief in the Associated Complaints of Mukhadushika (Acne Vulgaris) viz. Shotha (Inflammation), Kandu (Itching), Snigdha Tvaka (Oily skin), Vrana Vastu (Scar), Vaivarnya (Discolouration), Shotha (Inflammation) will be assessed.

Trial Locations

Locations (1)

Institute of Teaching and Research in Ayurveda Hospital; 🇮🇳 Jamnagar, GUJARAT, India

Institute of Teaching and Research in Ayurveda Hospital

🇮🇳Jamnagar, GUJARAT, India

Dr Shubhangi Kamble

Principal investigator

9428400109

shubhangikamble@itra.edu.in