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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.
Cureus
|January 13, 2026
Summary
SHL 1066 significantly improved sperm count, motility, and sexual health in men with low sperm counts. This polyherbal formulation offers a promising, safe option for male infertility management.
Area of Science:
- Reproductive Medicine
- Andrology
- Herbal Medicine
Background:
- Male infertility, specifically oligospermia (low sperm count), is a widespread clinical issue with complex causes and few effective treatments.
- Current therapeutic avenues for male infertility are limited, necessitating research into novel interventions.
Purpose of the Study:
- To evaluate the efficacy and safety of SHL 1066, a standardized polyherbal formulation, in improving semen quality and sexual health in men diagnosed with low sperm counts.
- To assess the impact of SHL 1066 on sperm count, motility, serum testosterone levels, and various sexual health parameters.
Main Methods:
- A 90-day, multicenter, randomized, double-blinded, placebo-controlled trial involving 60 male participants.
- Participants were randomized to receive either SHL 1066 or a placebo.
- Key assessments included sperm count, motility, serum total testosterone, and sexual health metrics (erectile function, intercourse satisfaction, overall satisfaction) at baseline and study completion.
Main Results:
- SHL 1066 treatment resulted in a significant increase in sperm count (72.5%) and motility (14.4%) compared to placebo.
- Serum total testosterone levels increased by 23.3% in the SHL 1066 group.
- Marked improvements were observed in sexual health outcomes, including erectile function (45.5%), intercourse satisfaction (52.8%), and overall satisfaction (54%), significantly outperforming the placebo group.
Conclusions:
- SHL 1066 demonstrated significant efficacy and a favorable safety profile in improving key markers of male reproductive health and sexual function.
- The polyherbal formulation effectively enhanced sperm count, motility, testosterone levels, and sexual health parameters compared to placebo.
- These findings suggest SHL 1066 is a potentially valuable therapeutic agent for addressing male infertility and improving overall sexual well-being.
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