Clinical evaluation of Unani formulations in the management of Busoor Labaniyah (Acne vulgaris).

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.