Comparative efficacy of Vrushadi Vati versus Tablet Clomiphene Citrate in the Management of Kshina Shukra (Oligospermia): A Randomised Clinical Trial Protocol

Introduction: Infertility is defined as the failure of a couple to conceive after one year of regular, unprotected sexual activity. Oligospermia is one of the causes of male infertility, when there are fewer than 20 million sperm per millilitre of semen. In Ayurveda, oligospermia is correlated with Kshina Shukra. Need of the study: A study on oligospermia is needed to address the growing concern of male infertility, which affects many couples and often has limited treatment options. Modern medicines such as Clomiphene citrate and Letrozole, which have long been used in the management of oligospermia, may be associated with adverse effects including dizziness, visual disturbances, flushing (skin redness), headaches, and nasal congestion. Vrushadi Vati, a herbal compound mentioned in Harita Samhita, contains Rishbhak (Malaxis muscifera), Bruhti (Solanum indicum), Kantakari (Solanum xanthocarpum), Pippali (Piperlongum), Gokshur (Tribulus terrestris), Kapikacchu (Mucuna pruriens), Shatavari (Asparagus racemosus), and Sharkara (white sugar), all of which possess aphrodisiac properties. No previous study has been conducted on Vrushadi Vati in Kshina Shukra (oligospermia). Aim: Evaluation of comparative efficacy of Vrushadi Vati versus Tab Clomiphene citrate in the management of Kshina Shukra (oligospermia). Materials and Methods: This will be a randomised controlled trial conducted at the Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod (H), Wardha, from March 2024 to February 2026. Patients will be randomly divided into two groups using a computerised method, each having 22 patients: Group A (n=22): Tab Clomiphene citrate (control group), Group B (n=22): Vrushadi Vati (experimental group). Treatment will be administered for 90 days. Follow-up will occur on the 30th, 60th, and 90th day, with parameters including sperm count and sperm motility assessed on the 30th and 90th days. Statistical analysis will be performed using the Wilcoxon signedrank test. Assessment parameters will be compared before and after treatment within each group by performing paired t-tests and between groups using unpaired t-tests. A p-value <0.05 will be considered statistically significant.