AN OPEN LABEL SINGLE ARM CLINICAL STUDY TO EVALUATE THE COMBINED EFFICACY OF MADHUTAILIKA BASTI AND KAMINI VIDRAVANA RASA IN THE MANAGEMENT OF KLAIBYA VIS-À-VIS ERECTILE DYSFUNCTION

Erectile dysfunction (ED), clinically correlated with Klaibya in Ayurveda, is a multifactorial disorder involving impaired erection, reduced rigidity, altered ejaculation, diminished sexual desire and psychological factors such as performance anxiety. The present open-label, single-arm clinical study was conducted to evaluate the combined efficacy of Madhutailika Basti followed by Kaminī Vidravaṇa Rasa in the management of Klaibya vis-à-vis ED. A total of 37 subjects were registered, of whom 30 subjects aged 21–59 years completed the study, while 7 were dropouts due to irregular follow-up; two of the registered subjects developed rectal bleeding on the third day of Basti. Subjects were selected from Government Ayurveda Medical College and Hospital, Mysuru, and Government Hi-Tech Panchakarma Hospital, Mysuru. Following appropriate preparatory management, Madhutailika Basti was administered for eight days, followed by Kaminī Vidravaṇa Rasa 125 mg once daily with Kṣīra as Anupana for the prescribed duration. Therapeutic response was assessed using clinical parameters including sexual desire, erection, penile rigidity, performance anxiety, ejaculation and orgasm, along with the International Index of Erectile Function (IIEF), at baseline and subsequent assessment points. Progressive improvement was observed across the assessed parameters. Sexual desire improved by 11.72% on Day 56 and 19.53% on Day 72; erection improved by 47.62%, 76.19% and 142.86% on Days 9, 56 and 72, respectively; rigidity improved by 88.89%, 155.56% and 222.22%; performance anxiety improved by 21.43% and 28.57% on Days 56 and 72; and ejaculation improved by 26.32%, 73.68% and 94.74%, respectively. The maximum improvement was observed in orgasm, with 85.71%, 242.86% and 328.57% improvement on Days 9, 56 and 72, respectively. Overall, the findings suggest that the combined intervention produced progressive improvement in multiple physical and psychological dimensions of sexual function, possibly through Vata regulation, Apana Vayu modulation, Śukra Dhatu nourishment, Vajīkaraṇa and improvement of psychosexual function. However, considering the small sample size, single-arm design, convenience sampling and absence of a control group, these findings should be regarded as preliminary and require confirmation through larger, controlled clinical studies.