Efficacy of Majoon and Tila Barse Aswad in Lichen planus - An open labelled single arm clinical study

Lichen planus(LP) is an idiopathic subacute or chronic inflammatory, Autoimmune, Mucocutaneous, Papulosquamous disorder that may affect the skin, scalp, nails and mucus membrane. Cutaneous lichen planus clinically characterized by distinctive violaceous, polygonal flat-topped pruritic papules which lines (Wickham’s striae) visible on the surface.

The exact incidence and prevalence of lichen planus are unknown, but the overall prevalence is believed to be somewhat 0.2% to 1% of the general population. Estimates between 0.14% and 0.27% have been reported worldwide and 0.38% in India. There is no sexual predilection and two- third of cases occurs between the 3rd and 6th decade of age4,6But Females are more prone to develop and  usually affecting in their 50s and 60s whereas males develop lichen planus at a somewhat earlier age. It develop adverse effects on quality of life in more than 90% of patients like psychological stress, social phobia, obsessive thoughts and cosmetologically disfigurement. There is strong association between depression and quality of life in both the gender.

In conventional medicine management of Lichen planus is challenging and can be discouraging for both, the patients and physician. Various oral drugs or topical corticosteroids have been used for treatment but many of recommended treatment lack conclusive evidence or efficacy and also show many side effects, drug resistance and interfere with immunity. So, alternative therapeutic approaches are being carried out. Through Unani herbal medicines could be solve by effective treatment with fewer side effects, enhance productivity, improve Quality of life.

In Unani System of medicine, direct description on LP is not available as such but according to its clinical presentation can be considered as Barse Aswad. The need of this study is to evaluate effectiveness of this classical unani preparation clinically, in this disease. So, Keeping all these in mind this study is planned for management of lichen planus with Unani medicine. Further according to the involvement of Madda we could relate it with khilt-e-saudawi (Melancholic humour).

So, according to this hypothesis it can be treated effectively with Majoon to expel out excessive and abnormal Sauda ( Melencholic Humour) from the whole body and appropriate Local application for symptomatic relief like itching and scaling etc. The Majoon used in this study contains Halela Siyah, Haleela Kabli, Aftimoon, Mawez munaqqa have Munzij Sauda Property and Tila Barse Aswad contains Barge Kaner, Mom, Gandhak and Roghan-e-kunjad to be administered orally and locally respectively.

Procedure of study**:** Patients with clinical features of LP fulfilling the inclusion criteria will be enrolled for the clinical trial. After obtaining their written informed consent and subsequently will be included in the study. The patients will be prescribed test drug in the form of Majoon orally and Tila for local application for 42 days with follow ups for assessment on every 14th day(14th day, 28th day, 42th day) . Before and after completion of trial, photographs of skin lesions will be taken for assessment  by an expert panel. The pre and post treatment objective findings (effects) will be assessed statistically.