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

Primary Purpose

Male Infertility

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Korean Red Ginseng (KRG)
Varicocelectomy
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Infertility focused on measuring Effects of Korean Red Ginseng on semen parameters in male infertility patients: a randomized, placebo-controlled, double-blind clinical study

Eligibility Criteria

25 Years - 45 Years (Adult)MaleDoes not accept 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.

Sites / Locations

  • Department of Urology, Pusan National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

V + KRG group (n = 20)

non-V + KRG group

V + P group (n = 20)

non-V + P group

Arm Description

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

three capsules of KRG (500 mg/dose) daily

placebo capsules and varicocelectomy

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
April 24, 2014
Last Updated
August 27, 2018
Sponsor
Pusan National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02204826
Brief Title
Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study
Official Title
Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
Effects of Korean Red Ginseng on semen parameters in male infertility patients: a randomized, placebo-controlled, double-blind clinical study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V + KRG group (n = 20)
Arm Type
Experimental
Arm Description
three capsules of KRG (500 mg/dose) daily and varicocelectomy.
Arm Title
non-V + KRG group
Arm Type
Active Comparator
Arm Description
three capsules of KRG (500 mg/dose) daily
Arm Title
V + P group (n = 20)
Arm Type
Active Comparator
Arm Description
placebo capsules and varicocelectomy
Arm Title
non-V + P group
Arm Type
Placebo Comparator
Arm Description
non-V + P group (n = 20) placebo capsules
Intervention Type
Drug
Intervention Name(s)
Korean Red Ginseng (KRG)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Varicocelectomy
Intervention Description
Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.
Primary Outcome Measure Information:
Title
Semen parmaters change from baseline to post-treatment
Description
1) sperm concentration, 2) percent motility, 3) sperm viability, and 4) Kruger/strict morphology using World Health Organization (WHO) methodologies (4th edition).
Time Frame
Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond)
Secondary Outcome Measure Information:
Title
Changes in hormonal parameters after treatment
Description
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.
Time Frame
Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Jun Park, PhD, MD
Organizational Affiliation
Department of Urology, Pusan National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of

12. IPD Sharing Statement

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

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