An open label single arm clinical study to evaluate the combined efficiency of Madhutailika basti and Kamini vidravana rasa in the management of Klaibya vis a vis Erectile dysfunction

Erectile dysfunction (ED) is the failure to achieve erection, ejaculation, or both. It affects 10-25% of middle-aged and elderly men. ED may result from three basic mechanisms: failure to initiate (psychogenic, endocrinologic, or neurogenic); failure to fill (arteriogenic); and failure to store adequate blood volume within the lacunar network (vasculogenic dysfunction). ED is the most common burning issue in males, recent hospital-based study from Southern India has reported the prevalences of ED and Premature ejaculation to be 48% and 43%, respectively. ED is a major cause of Impotency. In Western medical science, the management of ED includes oral medication Phosphodiesterase (PDE) 5 inhibitors (sildenafil, Tadalafil), Testosterone replacement, Androgen therapy, Intra urethral alprostadil, and intra cavernosal injection. These hormonal therapies have their own complications such as patients may experience Nausea, Bradycardia, Gastric irritation, and Bloating of the guts. Prolonged usage of such medications leads to Gynecomastia, Obscured vision, photophobia, stomach and pelvic pain, Benign Prostatic Hyperplasia, and Prostatic cancer. These treatment modalities have limitations, not feasible, time-consuming, expensive, are not patient-friendly. The absence of sexual function hampers marital relationships and sometimes ends in divorce. Thus there is a need to develop an elective and viable management to overcome the burning issue in the present day. Klaibya / kleebata which is mentioned under Shukravaha srotovikara in Ayurveda can be co related to Erectile dysfunction. Klaibya is defined as “Klaibyam Ithi Dvajanucharyam”, the condition in which lack of erection/absence of erection is due to distinct etiological factors. Ayurveda opines that the pathophysiology of klaibya is mainly due to Shukravaha srotodusti and Vatadosha, among these Charaka Samhita specifies the involvement of Vyana and Apana vayu. To get over this condition, and for vitiated vatadosha, Basti5 is the best line of treatment. hence they basically concentrate on Madhutailika basti6 as prime Vrishya basti, because it has properties like Vyapadam cha api asambhavaha and no specific parihara Vishaya should be followed. Kamini vidravana rasa is one such Rasoushadi said to be a vrishya. It is a Herbo-mineral medicine and has aphrodisiac properties that play an important role in the management of ED. It has the potential to improve sexual performance by improving stamina, Vigor, hardness of organ, and delaying the time of ejaculation. The study intends to evaluate the combined effect of Madhutailika basti and kaminin vidravana rasa.