Clinical evaluation of spermatogenic activity of processed Shilajit in oligospermia.
Level 4 - case-series / case-control
Uncontrolled single-arm before-and-after clinical study (case series design).
PubMed 20078516 · doi:10.1111/j.1439-0272.2009.00956.x
What was done
Thirty-five infertile men with sperm counts under 20 million/mL were enrolled to receive 100 mg of processed Shilajit capsules twice daily after major meals for 90 days. Semen parameters, serum hormones (testosterone, luteinising hormone, follicle-stimulating hormone), seminal malondialdehyde (MDA), and hepatic and renal safety markers were evaluated before and after treatment.
What was found
In the 28 patients who completed the 90-day protocol, significant improvements were seen compared to baseline: spermia volume increased by 37.6% (P < 0.001), total sperm count increased by 61.4% (P < 0.001), motility improved (12.4% to 17.4% at different time intervals), normal sperm count increased by 18.9%, and semen MDA decreased by 18.7%. Serum testosterone rose by 23.5% (P < 0.001) and FSH by 9.4% (P < 0.05). Hepatic and renal profiles remained unaltered.
Why it matters
This study provides preliminary clinical evidence that processed Shilajit may improve semen quality and hormone profiles in oligospermic infertile men.
Limits
The trial was uncontrolled and unblinded, making it susceptible to regression to the mean and placebo effects. The sample size was small (35 enrolled, 28 completed, 20% loss to follow-up), and functional fertility outcomes such as pregnancy rates were not reported.
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