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

NCT02204826 | Completed Phase 4 DMC

• 1 other identifier: KRG-infertility
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Male Infertility

Keywords

Effects of Korean Red Ginseng on semen parameters in male infertility patients: a randomized, placebo-controlled, double-blind clinical study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in hormonal parameters after treatment

  Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond)

Study Arms (4)

V + KRG group (n = 20)

EXPERIMENTAL

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

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

non-V + KRG group

ACTIVE COMPARATOR

three capsules of KRG (500 mg/dose) daily

Drug: Korean Red Ginseng (KRG)

V + P group (n = 20)

ACTIVE COMPARATOR

placebo capsules and varicocelectomy

Procedure: Varicocelectomy

non-V + P group

PLACEBO COMPARATOR

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

Drug: Korean Red Ginseng (KRG)

Interventions

Korean Red Ginseng (KRG) DRUG

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.

V + KRG group (n = 20); non-V + KRG group; non-V + P group

Varicocelectomy PROCEDURE

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

V + KRG group (n = 20); V + P group (n = 20)

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Department of Urology, Pusan National University Hospital

Busan, 602-739, South Korea

Location

MeSH Terms

Conditions

Infertility, Male

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Hyun Jun Park, PhD, MD

  Department of Urology, Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: July 30, 2014
• Study Start: April 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2013
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

KR (1)