Evaluation of Standard Market Preparation Tablet (Tentex Forte) and Vrishya Gutika in the Management of Klaibya (Erectile Dysfunction): Research Protocol for a Randomised Controlled Tria

Introduction: Klaibya is a sexual dysfunction characterised by various symptoms, including Ling Shaithilya (penis shrinkage) and Mlan Shishna (penis weakening). It refers to a man’s inability to engage in sexual acts satisfactorily, leaving the female partner either partially or completely unsatisfied. The Charak Samhita mentions Vajikaran (aphrodisiac) Yoga as a remedy for Klaibya. Need of the Study: Common modern medications used to treat Klaibya include Cialis, Viagra, Levitra and Stendra. However, these drugs can lead to several side-effects, such as headaches, body aches, gastrointestinal disturbances, dizziness, vision changes, flushing, nasal congestion and in some cases, priapism (an erection lasting longer than four hours) and sudden changes in hearing. On the other hand, Vrishya Gutika, an herbal formulation mentioned in the Charak Samhita, includes ingredients like Vidarikand Swaras, Tugaksheeri Churna, Sharkara Churna, Ikshurak Churna (Kokilaksha), Pippali Churna, and Kappikacchu Beej Churna, along with cow ghee, cow milk, and honey-all known for their aphrodisiac properties. Aim: To conduct a comparative evaluation of the efficacy of Vrishya Gutika and Tablet Tentex Forte in the management of Klaibya (Erectile Dysfunction). Materials and Methods: A single-blinded, randomised controlled trial will be conducted at the Kayachikitsa outpatient and inpatient departments of Mahatma Gandhi Ayurved College, Hospital, and Research Centre in Salod (H), Wardha, Maharashtra, India from March 2023 to February 2025. Two groups will be formed, each consisting of 30 subjects. Group A will serve as the control group and will receive a standard market preparation (Tentex Forte)-two tablets twice daily. Group B, the trial group, will receive Vrishya Gutika-four tablets twice daily, both for 30 days. The effectiveness of the interventions will be evaluated using a validated questionnaire. The paired t-test will be employed to assess subjective parameters within the same group, while the unpaired t-test will be used for intergroup comparisons, establishing a significance level of <0.05.