Journal of Clinical Nutrition & Dietetics

Effect of a Polyherbal Dietary Supplement on Semen Characteristics: A Randomized, Double-Blind Placebo-Controlled Clinical Trial

Context: Ejaculate volume, an important semen characteristic, plays a significant role in male fertility. There is a growing need to find supplements to increase ejaculate volume.

Objective: The primary objective of the study was to evaluate the efficacy and safety of a dietary supplement (SemenaxTM) on semen characteristics of hypospermic and normospermic men.

Design: A double-blind, randomized placebo-controlled exploratory clinical trial.

Setting: Six clinical sites 3 at Nasik, 2 at Pune and 1 at Mumbai, Maharashtra, India.

Participants: Males aged 30 Years-60 years (n=78) diagnosed with hypospermia/normospermia with low ejaculate volume; normozoospermia; mild to moderate oligozoospermia; impairment of sperm motility and morphology and erectile dysfunction.

Intervention: The participants were randomized in a ratio of 1:1 to receive the supplement (3200 mg in two divided doses) or placebo for two months.

Main outcome measures: Main outcomes were mean change in ejaculate volume, sperm characteristics, sexual function, and orgasm quality from baseline to end of the study compared to placebo. In addition the safety of the supplement was evaluated by questionnaires, vitals and laboratory parameters.

Results: The supplement significantly increased the ejaculate volume from the baseline values compared to the placebo (19.67% vs. 8%). The number of responders in the supplement group was significantly more than in the placebo group (50% vs. 16%). Orgasm quality was improved in 65.63% of participants compared to 41.9% in placebo. No major safety concerns were reported in both groups.

Conclusion: Overall, the dietary supplement effectively improved the ejaculate volume to significant levels without any significant adverse effects.

Keywords: Semen; Dietary supplement; Ejaculate volume; Hypospermia; Normospermia; Orgasm; Sexual function; Erectile dysfunction

Abbreviations: AE: Adverse Event; ANOVA: Analysis of Variance; CBC: Complete Blood Count; CONSORT; Consolidated Standards of Reporting Trials; ECG: Electrocardiogram; EDTA: Ethylenediamine Tetra-Acetic Acid; EF: Erectile Function; ESR: Erythrocyte Sedimentation Rate; ICH-GCP: International Conference on Harmonization-Good Clinical Practices; ICMR: Indian Council of Medical Research; IIEF: International Index of Erectile Function; IP: Investigational Products; ITT: Intention-To-Treat; PP: Per-Protocol; SD: Standard Deviation; SGPT: Serum Glutamic Pyruvic Transaminase; WHO: World Health Organization

Author(s): Doug MacKay1*, Sonika Verma2 and Shalini Srivastava3

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