Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study

Pusan National University

Status and phase: Completed; Phase 4

Conditions: Male Infertility

Treatments: Procedure: Varicocelectomy; Drug: Korean Red Ginseng (KRG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02204826

KRG-infertility

Details and patient eligibility

About

Korean Red ginseng (KRG) has long been applied to various diseases as a health-promoting herbal medicine in Korea. Many clinical studies of ginseng have been performed to elucidate its therapeutic characteristics. KRG has been shown to be effective in many diseases, such as cancers, hypertension, Alzheimer's disease, diabetes, acquired immune deficiency syndrome, and sexual dysfunction. Several studies have indicated effects of ginseng on improving spermatogenesis in animals. The major mechanisms behind these effects were speculated to be anti-oxidant and anti-aging effects, as well as modulation of the hypothalamus-pituitary-testis axis [7 - 10]. However, there have been no controlled human clinical trials to evaluate the effects of KRG on spermatogenesis in patients with male infertility.

Only a small proportion of causes of male infertility are currently curable, including male hypogonadal disorders that can be cured by gonadotropic agents, and obstructive azoospermia that can be corrected by surgery. In addition, evidence-based medicine has revealed that most empirical treatments are ineffective. Similarly, the efficacies of carnitine, anti-estrogens, kallikrein, vitamins C and E, and glutathione have not been confirmed.

Therefore, the investigators investigated the effects of KRG on semen parameters in male infertility patients. This is the first placebo-controlled trial to evaluate the therapeutic effects of KRG in male patients.

Enrollment: 80 patients

Sex: Male

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients should be males, 25 - 45 years of age, who had complained of infertility for at least 12 months, and had no history of surgical or medical treatments for infertility.

• Increased retrograde flow in the internal spermatic vein with venous diameter > 3 mm during the Valsalva maneuver on scrotal ultrasonography was used as an indicator of varicocele [13].

• Varicocele was graded according to the criteria presented by Lyon et al. [14]: *Grade I, palpable only with the Valsalva maneuver

  • Grade II, palpable without the Valsalva maneuver
  • Grade III, visible from a distance.

Exclusion criteria

• A history of vasectomy or obstructive azoospermia
• Chromosomal abnormalities
• Hypogonadism or pituitary abnormalities
• Anatomical abnormality of the genitals
• Significant hepatopathy (liver enzymes elevated 2 - 3-fold higher than the normal range)
• Renal insufficiency (serum creatinine level > 2.5 mg/dL)
• Medical treatment for infertility during the past 4 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

V + KRG group (n = 20)

Experimental group

Description:

three capsules of KRG (500 mg/dose) daily and varicocelectomy.

Treatment:

Drug: Korean Red Ginseng (KRG)

Procedure: Varicocelectomy

non-V + KRG group

Active Comparator group

Description:

three capsules of KRG (500 mg/dose) daily

Treatment:

Drug: Korean Red Ginseng (KRG)

V + P group (n = 20)

Active Comparator group

Description:

placebo capsules and varicocelectomy

Treatment:

Procedure: Varicocelectomy

non-V + P group

Placebo Comparator group

Description:

non-V + P group (n = 20) placebo capsules

Treatment:

Drug: Korean Red Ginseng (KRG)