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

Male Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204826
• Other study ID #: KRG-infertility
• Status: Completed
• Phase: Phase 4
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2018
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Drug:
• Korean Red Ginseng (KRG)
The KRG capsules were provided by Korean Ginseng Corporation (Daejeon, Korea). KRG powder was manufactured from roots of a 6-year-old red ginseng, Panax ginseng Meyer, harvested in Republic of Korea. KRG was made by steaming fresh ginseng at 90-100 ?C for 3 h and then drying at 50-80 ?C. KRG powder prepared from grinded red ginseng (KRG capsule : 500mg/capsule). KRG was analyzed by high-performance liquid chromatography. KRG extract contained major ginsenoside-Rb1: 4.26mg/g, -Rb2: 1.62mg/g, -Rc: 1.80mg/g, -Rd: 0.29mg/g, -Re: 1.71mg/g, -Rf: 0.67mg/g, -Rg1: 2.61mg/g, -Rg2: 0.20mg/g, -Rg3: 0.13mg/g, and other minor ginsenosides. During the study period, three capsules were taken daily for 12 weeks.

Procedure:
• Varicocelectomy
Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology, Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semen parmaters change from baseline to post-treatment	1) sperm concentration, 2) percent motility, 3) sperm viability, and 4) Kruger/strict morphology using World Health Organization (WHO) methodologies (4th edition).	Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond)
Secondary	Changes in hormonal parameters after treatment	Serum concentrations of FSH and LH were measured using chemiluminescence assays, and serum total testosterone was quantified by radioimmunoassay. The hormonal status of all patients was recorded at the initial screening visit and post-treatment.	Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond)