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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02204826
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hyun Jun Park, Pusan National University Hospital

Tracking Information
First Submitted Date  ICMJE April 24, 2014
First Posted Date  ICMJE July 30, 2014
Last Update Posted Date August 29, 2018
Study Start Date  ICMJE April 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
Semen parmaters change from baseline to post-treatment [ Time Frame: Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond) ]
1) sperm concentration, 2) percent motility, 3) sperm viability, and 4) Kruger/strict morphology using World Health Organization (WHO) methodologies (4th edition).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
Changes in hormonal parameters after treatment [ Time Frame: Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond) ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study
Official Title  ICMJE Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Male Infertility
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: V + KRG group (n = 20)
    three capsules of KRG (500 mg/dose) daily and varicocelectomy.
    Interventions:
    • Drug: Korean Red Ginseng (KRG)
    • Procedure: Varicocelectomy
  • Active Comparator: non-V + KRG group
    three capsules of KRG (500 mg/dose) daily
    Intervention: Drug: Korean Red Ginseng (KRG)
  • Active Comparator: V + P group (n = 20)
    placebo capsules and varicocelectomy
    Intervention: Procedure: Varicocelectomy
  • Placebo Comparator: non-V + P group
    non-V + P group (n = 20) placebo capsules
    Intervention: Drug: Korean Red Ginseng (KRG)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2014)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02204826
Other Study ID Numbers  ICMJE KRG-infertility
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hyun Jun Park, Pusan National University Hospital
Study Sponsor  ICMJE Pusan National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hyun Jun Park, PhD, MD Department of Urology, Pusan National University Hospital
PRS Account Pusan National University Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP