Evaluation of efficacy and safety of Unani formulation in Acne
Phase 2
- Conditions
- Health Condition 1: null- Acne Vulgaris
- Registration Number
- CTRI/2017/07/009004
- Lead Sponsor
- Dept of Moalajat Jamia Hamdard
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with moderate to severe acne (score of acne 19-38), as per the Global Acne Grading System (GAGS).
Exclusion Criteria
Pregnant and lactating women.
Patients using hormonal contraceptives.
Patients suffering from PCOD.
Patients suffering from other concomitant skin diseases.
Patients having liver & renal diseases.
Patients using drugs known to be photo sensitizers and anti-androgenic drugs.
Patients who have used topical anti-acne medications within the past two weeks.
Patients who have used systemic antibiotic within past one month.
Patients who have used isotretinoin in the last six months.
Patients using medications that are reported to exacerbate acne.
Patients have had chemical or laser peel & artificial UV therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GAGS Scale (Global Acne Grading System).Timepoint: 0 Day, 14th Day, 28th Day, 42nd Day, 56th Day
- Secondary Outcome Measures
Name Time Method Coloured photographs of the lesion with the same magnification. <br/ ><br> <br/ ><br>Timepoint: 0 Day & 56th Day;Likert scale: Itching, erythema & scaring will be assessed on likert scale (0-3)Timepoint: 0 Day, 14th Day, 28th Day, 42nd Day, 56th Day;safety parameters include (CBC with ESR, LFT, KFT, U-R/MTimepoint: 0 Day & 56th Day <br/ ><br>;The Cardiff Acne Disability Index - to assess quality of lifeTimepoint: 0 Day, 28th Day, 56th Day