RÉSUMÉ
Background: Sida cordifolia Linn. is a well-known medicinal plant which exhibits anti-inflammatory, antioxidant, and sexual properties. It shows good promise in the treatment of male sexual disorders during its pre-clinical studies. Objective: The objective of the study was to assess the spermatogenesis action of aqueous extract of roots of S. cordifolia Linn. in clinical trials. Materials and Methods: The study uses qualitative criteria such as primary and secondary symptoms, and quantitative investigations such as hematological investigations, hormonal analysis, and semen analysis for assessing the therapeutic efficacy of research formulation through placebo-controlled clinical trials on 50 males having lack of sexual desire and non-satisfactory sexual life. Results: Very high inhibition was noticed in respect of primary symptoms such as lack of libido, difficulty in ejaculation or little amount of semen, as well as secondary symptoms such as nausea, body ache, headache, indigestion, loss of appetite, and general weakness in the research group. Lack of any adverse changes in hematological parameters (blood sugar, hemoglobin, ESR, RBC, and WBC) and biochemical parameters (bilirubin, protein, SGPT, SGOT, and ALP) indicates the non-toxic nature of research formulation. The hormonal levels registered a significant increase during the clinical study in research group, especially the testosterone level (8.53%). Semen quality evaluated through sperm count, motility, and morphology showed a significant improvement in research group, suggesting that administration of research drug in cases of stress-related sexual problems protected healthy cells by reduced generation of ROS and helped maintain quality parameters of spermatozoa during spermatogenesis. Conclusion: The research formulation made from roots of S. cordifolia Linn. shows good and significant (P < 0.05) therapeutic efficacy through inhibition of primary and secondary symptoms and enhancement in hormonal and seminal parameters, validating its spermatogenesis effect without any toxic or adverse effects.