A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Efficacy and Safety of a Polyherbal Unani Formulation in the Management of Buthūr Labaniyya (Acne Vulgaris)

ButhÅ«r Labaniyya  (Acne Vulgaris) is a disease of pilosebaceous unit, where lesions develop in the upper-portion of follicular canal, manifests as comedons, papules, pustules and heals with scar. It usually affects 80-90% of individuals at the time of puberty. Both the sex is equally affected. The term ButhÅ«r Labaniyya refers to a whitish discharge resembling milk from eruption. The drugs used in conventional medicine are effective, but shows after-effects after prolonged use. Hence, the safe and effective treatment for acne is required. In Unani Medicine, the drugs have JÄli, Muḥallil, Muá¹£affÄ«-i-Dam properties, but data regarding their efficacy and safety is unavailable. Hence, this clinical trial has been planned to evaluate the efficacy and safety of a polyherbal unani formulation in comparison to benzoyl peroxide 5% gel in the management of acne vulgaris. The participants fulfilling inclusion criteria will be randomly allocated to either of the groups. In test group, the patient will be given unani formulation for local application once daily at bedtime and in control group, the patients will be given benzoyl peroxide 5% gel to be applied locally once daily at bedtime.  Baseline and last follow-up laboratory investigations will be done. Duration of study is 6 weeks

Statistical Analysis: Student t test will be used to find the statistically significant difference in the parameters within the group/ inter the group. all the result analysis will be done using MS excel 2019.