Effect of Fermented Ginseng (GINST) on Sperm Motility
キーワード
概要
説明
This multicenter, randomized, double-blind, placebo-controlled clinical trial was aimed to evaluate of sperm motility improvement effect of fermented ginseng(GINST). Experimental arm and control arm were randomly assigned among the volunteers who met the inclusion criteria: men between the ages of 18 and 60 who had sperm motility of less than 32%.
To experimental arm, capsules including 160mg of fermented ginseng(GINST) ingredients will be provided for 12 weeks. To control arm, capsules of the same shape and weight as GINST capsules will be provided. These capsules are made of a cellulose component.
Primary outcome is sperm motility. Secondary outcome are
日付
| 最終確認済み: | 05/31/2017 |
| 最初に提出された: | 05/16/2017 |
| 提出された推定登録数: | 06/08/2017 |
| 最初の投稿: | 06/11/2017 |
| 最終更新が送信されました: | 06/08/2017 |
| 最終更新日: | 06/11/2017 |
| 実際の研究開始日: | 01/25/2017 |
| 一次完了予定日: | 11/30/2017 |
| 研究完了予定日: | 12/30/2017 |
状態または病気
介入/治療
Dietary Supplement: GINST group
Dietary Supplement: Control group
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: GINST group Experimental group was randomly assigned among the volunteers who met the inclusion criteria: men between the ages of 18 and 60 who had sperm motility of less than 32%. Fermented ginseng (GINST) was supplied. | Dietary Supplement: GINST group Intervention group should take fermented ginseng (GINST) capsule 3 times a day, 2 capsules at one time for 12 weeks |
| Placebo Comparator: Control group Control group was randomly assigned among the volunteers who met the inclusion criteria: men between the ages of 18 and 60 who had sperm motility of less than 32%. Placebo was supplied. | Dietary Supplement: Control group Control group should take placebo capsule 3 times a day, 2 capsules at one time for 12 weeks |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | Male |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Male between 18 and 60 years old - Men who have agreed to participate in this trial before the start of the study and who have written an informed consent Exclusion Criteria: - Those who are diagnosed and treated for hypertension (systolic blood pressure> 140mmHg and diastolic blood pressure> 90mmHg) - Patients with a history of chemotherapy for malignant tumors - Patients with a history of taking testosterone or antiandrogens within 1 month - BMI> 30 or BMI <18 - Those who have the following results in the blood test: AST(aspartate aminotransferase ), ALT(Alanine transaminase) > 2 times the upper limit of reference range; Serum Creatinine> 2.0 mg / dl - Those who ingested drugs (eg, folic acid, L-carn, HCG(human chorionic gonadotropin ), FSH(Follicle-stimulating hormone), Clomiphene, etc.) that have an effect on sperm motility within 2 weeks before the screening day. - Persons who have received antipsychotic medication within 2 months before the screening test - Those who have history of alcoholism or substance abuse |
結果
主な結果の測定
1. Sperm motility [Change from baseline sperm motility at 12 weeks]
二次的な結果の測定
1. Quality of life [Change from baseline quality of life at 12 weeks]
2. Fatigue questionnaire [Change from baseline Fatigue Severity Scale at 12 weeks]
3. Sexual function [Change from baseline Sexual Function Inventory (questionnaire) at 12 weeks]
