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Efficacy and Safety of Polyherbal Formulation in Low Sperm Count Participants: A Randomized, Multicenter,
Pramod Kolsure1, Sanman Kolhe2, Aditya Dev2
1Formulation and Development, Formulation Development Team, SAVA Healthcare Limited, Pune, IND.
Introduction:
Male infertility, particularly oligospermia, is characterized by reduced sperm count. It remains a significant clinical concern due to its multifactorial origin and limited therapeutic options. The present study investigates the efficacy and safety of "SHL 1066," a standardized polyherbal formulation, in enhancing semen quality and improving sexual health outcomes in men with low sperm counts.
Materials And Methods:
In a 90-day, multicenter, randomized, double-blinded, placebo-controlled trial, 60 male participants were randomly assigned to receive either "SHL 1066" or a placebo using a computer-generated randomization protocol. Assessments of sperm count, motility, serum total testosterone, and sexual health parameters (erectile function, intercourse satisfaction, and overall satisfaction) were conducted at baseline and study completion.
Results:
After 90 days, "SHL 1066" significantly increased sperm count by 72.5% and motility by 14.4%, compared to 8.6% and 6.3%, respectively, in the placebo group. Serum total testosterone levels rose by 23.3%. Sexual health outcomes improved markedly, with erectile function enhanced by 45.5%, intercourse satisfaction by 52.8%, and overall satisfaction by 54%, substantially surpassing placebo outcomes.
Conclusion:
"SHL 1066" demonstrated safety, tolerability, and significant efficacy in improving sperm count, motility, testosterone levels, and sexual health compared to placebo. These results position "SHL 1066" as a promising therapeutic option for managing male infertility by enhancing semen quality and sexual function.
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