# Efficacy and Safety of Polyherbal Formulation in Low Sperm Count Participants: A Randomized, Multicenter, Double-Blinded, Placebo-Controlled, Interventional Study

**Authors:** Pramod Kolsure, Sanman Kolhe, Aditya Dev, Somesh S Shintre, Shrikant G Dhavale, Vinod Kuber, Sriram Padmanabhan

PMC · DOI: 10.7759/cureus.98844 · Cureus · 2025-12-09

## TL;DR

A herbal treatment called SHL 1066 significantly improved sperm count, motility, and sexual health in men with low sperm counts, outperforming a placebo.

## Contribution

This study provides clinical evidence for the efficacy and safety of a polyherbal formulation in treating male infertility.

## Key findings

- SHL 1066 increased sperm count by 72.5% and motility by 14.4% compared to placebo.
- Testosterone levels rose by 23.3%, and sexual health outcomes improved significantly.
- The treatment was safe and well-tolerated over 90 days.

## Abstract

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.

## Linked entities

- **Diseases:** oligospermia (MONDO:0001913)

## Full-text entities

- **Diseases:** Male infertility (MESH:D007248), oligospermia (MESH:D009845)
- **Chemicals:** SHL 1066 (-), testosterone (MESH:D013739)
- **Species:** Homo sapiens (human, species) [taxon 9606]

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## References

30 references — full list in the complete paper: https://tomesphere.com/paper/PMC12790483/full.md

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Source: https://tomesphere.com/paper/PMC12790483