Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study
الكلمات الدالة
نبذة مختصرة
تواريخ
| آخر التحقق: | 07/31/2018 |
| تم الإرسال لأول مرة: | 04/23/2014 |
| تم إرسال التسجيل المقدر: | 07/28/2014 |
| أول نشر: | 07/29/2014 |
| تم إرسال آخر تحديث: | 08/26/2018 |
| آخر تحديث تم نشره: | 08/28/2018 |
| تاريخ بدء الدراسة الفعلي: | 03/31/2011 |
| تاريخ الإنجاز الأساسي المقدر: | 01/31/2012 |
| التاريخ المتوقع لانتهاء الدراسة: | 11/30/2013 |
حالة أو مرض
التدخل / العلاج
Drug: Korean Red Ginseng (KRG)
Procedure: Varicocelectomy
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| Experimental: V + KRG group (n = 20) three capsules of KRG (500 mg/dose) daily and varicocelectomy. | |
| Active Comparator: non-V + KRG group three capsules of KRG (500 mg/dose) daily | |
| Active Comparator: V + P group (n = 20) placebo capsules and varicocelectomy | |
| Placebo Comparator: non-V + P group non-V + P group (n = 20) placebo capsules |
معايير الأهلية
| الأعمار المؤهلة للدراسة | 25 Years إلى 25 Years |
| الأجناس المؤهلة للدراسة | Male |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | 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. |
النتيجة
مقاييس النتائج الأولية
1. Semen parmaters change from baseline to post-treatment [Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond)]
مقاييس النتائج الثانوية
1. Changes in hormonal parameters after treatment [Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond)]
