Evaluation of efficacy and safety of Unani formulation in Acne
- Conditions
- Acne Vulgaris
- Registration Number
- CTRI/2017/07/009004
- Lead Sponsor
- Dept of Moalajat Jamia Hamdard
- Brief Summary
This study is a randomized, open label, standard controlled trial, comparing the safety and efficacy of test and control drugs. The **test drugs** comprises of topical drug: **Zimad-e-Muhasa** which is composed of *Irsa (Iris ensata* Thunb*),* *Barg-e-Neem (Azadirachta indica* A. Juss.*), Post-e-Siris (Albizia lebbeck*(L.) Benth.) , *Ghungchi safaid (Abrus precatorius* Linn.*)* and Namak-e-sambhar (Lake salt) in equal proportion to be applied as paste once daily and the oral drug is **Cap. Shahtra** 2 capsules twice daily equivalent to 5 g of dried aqueous extract of Barg-e-Shahtra (leaves of *Fumaria parviflora* Lam.)) and the **control drugs** includes topical drug: **benzoyl peroxide** 5% gel once daily and **Tab. Azithromycin** 500mg thrice weekly i.e.,on Mon,Wed, Fri ) for a period of 8 weeks in 60 patients randomly allocated into test and control groups i.e., 30 patients in each group with Acne vulgaris in moderate to severe category that will be conducted in Majeedia Unani Hospital, New Delhi India and HAHC Hospital Jamia Hamdard, New Delhi, India. The primary outcome measures will be GAGS (Global Acne Grading System) scale to assess improvement in lesions at baseline, 2nd week 4th week 6th week and 8 week The secondary outcomes will be photographs of lesions at baseline and 8 week, likert scale to assess itching, erythema and scaring at baseline, 2nd week 4th week 6th week and 8 week and Cardiff Acne Disability Index to assess quality of life at baseline 4th week and 8 week. The safety and tolerability of test and control will be assessed on clinical sign and symptoms and laboratory parameters including CBC with ESR, LFT, KFT Urine-R/M before and after treatment. USG-lower abdomen will be done to exclude women with PCOD. The study is approved by Board of studies (BOS) of the institution on 10th February 2017 and approved by Institutional ethics committee (IEC) of Jamia Hamdard on 24th may 2016.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 60
Patients with moderate to severe acne (score of acne 19-38), as per the Global Acne Grading System (GAGS).
- 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). 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. The Cardiff Acne Disability Index - to assess quality of life 0 Day, 28th Day, 56th Day Likert scale: Itching, erythema & scaring will be assessed on likert scale (0-3) 0 Day, 14th Day, 28th Day, 42nd Day, 56th Day safety parameters include (CBC with ESR, LFT, KFT, U-R/M 0 Day & 56th Day
Trial Locations
- Locations (1)
Clinical research OPD
🇮🇳South, DELHI, India
Clinical research OPD🇮🇳South, DELHI, IndiaDr Samreen khanPrincipal investigator8510023869dr.samreenkhan24@gmail.com