Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue
关键词
抽象
描述
Previous studies have indicated that Fermented Prunus Mume Vinega may have the ability to improve fatigue. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of tFermented Prunus Mume Vinega on Improvement of Fatigue in adults; the safety of the compound are also evaluate. The Investigators examine fatigue severity scale, lactate, creatinine kinase, urinary malondialdehyde at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 600 mg of Fermented Prunus Mume Vinega or a placebo each day for 8 weeks;
日期
| 最后验证: | 02/29/2020 |
| 首次提交: | 03/20/2020 |
| 提交的预估入学人数: | 03/22/2020 |
| 首次发布: | 03/23/2020 |
| 上次提交的更新: | 03/22/2020 |
| 最近更新发布: | 03/24/2020 |
| 实际学习开始日期: | 03/18/2020 |
| 预计主要完成日期: | 12/29/2020 |
| 预计完成日期: | 12/30/2020 |
状况或疾病
干预/治疗
Dietary Supplement: Fermented Prunus Mume Vinegar group
Dietary Supplement: Placebo group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Fermented Prunus Mume Vinegar group This group takes Fermented Prunus Mume Vinegar for 8 weeks. | Dietary Supplement: Fermented Prunus Mume Vinegar group This group takes Fermented Prunus Mume Vinegar for 8 weeks |
| Placebo Comparator: Placebo group This group takes placebo for 8 weeks. | Dietary Supplement: Placebo group This group takes placebo for 8 weeks. |
资格标准
| 有资格学习的年龄 | 19 Years 至 19 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Those who complain of fatigue for more than 1 month - Fatigue Severity Scale 3 points or more Exclusion Criteria: - chronic hepatitis B or C infection - being treated for hypothyroidism or hyperthyroidism - more than twice the normal upper limit of Creatinine - Liver enzyme value is more than twice the normal upper limit - Uncontrolled diabetes (over 160 mg / dl of fasting blood sugar) - Uncontrolled hypertension (more than 160/100 mmHg, measured after 10 minutes of stability in subjects) or those with heart disease, such as angina or myocardial infarction - taking medications that affect fatigue within the past 1 month (psychiatric drugs such as Chinese medicine, soy drugs, depression, beta-blockers, steroids, hormones, etc.). However, intermittent medication due to sleep disorders is excluded. - a history of gastrointestinal resection or complain of severe gastrointestinal symptoms such as heartburn and indigestion - already have participated in or plan to participate in another drug clinical trial - Alcohol abusers - pregnant, lactating or have a pregnancy plan during the clinical trial period - allergic reactions to Fermented Prunus Mume Vinegar - A person deemed inappropriate by the researcher for other reasons |
结果
主要结果指标
1. Fatigue severity scale [8 weeks]
次要成果指标
1. Lactate level [8 weeks]
2. Creatinine kinase level [8 weeks]
3. Urinary malondialdehyde level [8 weeks]
