EVALUATION OF A COMPREHENSIVE VAJIKARAṆA REGIMEN IN KLAIBYA: AN OPEN-LABEL RANDOMIZED CLINICAL TRIAL

Background: Erectile Dysfunction (ED), defined as the persistent inability to achieve or maintain an erection for satisfactory sexual activity, is a major global concern projected to affect over 320 million men by 2025. Ayurveda describes ED as Klaibya, primarily associated with Vata vitiation and Shukra dhatu kshaya. Vajikaraṇa therapy offers a holistic, multi-modal approach to its management. Objectives is to evaluate the efficacy of a combined Vajikaraṇa protocol comprising Guduchyamalakadi Kashaya for Ama pachana, Payasa Eranda Taila Kostashodhana, Ksheera Vaitarana Basti, Vidarikanda Taila Uttarabasti, Manmathabhra Rasa, and Shishna Lepa in the management of Klaibya. To assess the efficacy of Vidarikanda Ghana Vati with Shishna Lepa. To compare both modalities for relative therapeutic effectiveness. Methods: An open-labelled randomized controlled trial was conducted for 36 days on two groups. Group A received the comprehensive Vajikaraṇa regimen, while Group B received Vidarikanda Ghana Vati with Shishna Lepa. Subjective and objective outcomes were assessed before and after treatment and analysed using contingency tables. Results: Group A demonstrated highly significant improvement in all subjective parameters (P < 0.0001) compared to Group B. In hormonal markers, total testosterone improved markedly in Group A (P < 0.0001). Free testosterone and LH showed marginally better improvement in Group B. FSH showed a non-significant trend toward improvement in Group A. Prolactin and TSH remained unchanged in both groups. Conclusion: The comprehensive Vajikaraṇa protocol provided significantly superior improvement in psychosexual and physiological parameters of ED compared to the limited regimen. Multi-modal Ayurvedic interventions therefore offer enhanced therapeutic benefit in the management of Klaibya.