Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Semen parmaters change from baseline to post-treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
V + KRG group (n = 20)
three capsules of KRG (500 mg/dose) daily and varicocelectomy.
干预措施: Korean Red Ginseng (KRG) (Drug)
V + KRG group (n = 20)
three capsules of KRG (500 mg/dose) daily and varicocelectomy.
干预措施: Varicocelectomy (Procedure)
non-V + KRG group
three capsules of KRG (500 mg/dose) daily
干预措施: Korean Red Ginseng (KRG) (Drug)
V + P group (n = 20)
placebo capsules and varicocelectomy
干预措施: Varicocelectomy (Procedure)
non-V + P group
non-V + P group (n = 20) placebo capsules
干预措施: Korean Red Ginseng (KRG) (Drug)
结局指标
主要结局
Semen parmaters change from baseline to post-treatment
时间窗: 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).
次要结局
- Changes in hormonal parameters after treatment(Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond))
研究者
Hyun Jun Park
Professor
Pusan National University Hospital