Double Blinded, Randomized, Placebo-controlled Clinical Study for Evaluating Anti-stress Effects of Nelumbinis Semen by 2 Week Administration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Beck Depression Inventory (BDI)
研究概览
简要总结
Nelumbinis Semen, has been widely used as treatment of post-menopause symptoms in women for hundreds of years in many Asian countries. This study examines whether PM011, standardized herbal medicine made from Nelumbinis Semen, treats stress in above 5 of BDI score of human subjects and discusses its potential as treatment for depressed patients.
详细描述
Nelumbinis Semen, has been widely used as treatment of post-menopause symptoms in women for hundreds of years in many Asian countries. This study examines whether PM011, standardized herbal medicine made from Nelumbinis Semen, treats stress in above 5 of BDI score of human subjects and discusses its potential as treatment for depressed patients. Subjects were divided into three groups, the placebo-treated group (n = 10), the PM011-2.4 g treated group (n = 11) and PM011-4.8 g treated group (n = 11) per day. Alpha/Beta ratio of electroencephalogram (EGG), Beck Depression Inventory (BDI) and Stress Response Inventory (SRI) were conducted in order to measure changes in stress before and after 2 weeks of PM011 treatment.
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)
盲法说明
Double-blind study : Participants and investigators do not know which treatment is placebo or treatment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •\ * Volunteers were selected based on following meet conditions;Men and women, who have willingness and capacity to comply with the study protocol, are included if they were aged 18 to 65 years.
- •* Volunteers, who can understand Korean and English alphabet are selected.
- •* Volunteers, who can communicate with clinical trial performer fully, comply with the all tests and medical examinations performed by study protocol.
- •* All volunteers or their protectors understand purpose of study fully and sign their names or seal.
- •* Volunteers, who do not come under
排除标准
- •are selected.
- •* BDI score of Volunteers, who can be \>= 5.
- •\ * Volunteers were excluded if they are applied to following meet conditions; Volunteers with fasting glucose level over 126 mg/dl.
- •* Volunteers with hypertension as having over 140 mmHg of systolic blood pressure or 90 mmHg of diastolic blood pressure.
- •* Volunteers with blood thyroid stimulating hormone below 0.3 or over 4.0.
- •* Men with hemoglobin below 13.0 g/dl and women with hemoglobin below 12.0 g/dl.
- •* Volunteers with abnormality of liver function as having over 1.5 times of normal levels of ALT or AST.
- •* Patients with infections in upper airways or chronic diseases.
- •* Mental illness patients with such as alcoholism.
研究组 & 干预措施
PM011
PM011 is a 400 mg hard gelatin capsule containing water extracts of Nelumbinis Semen. The sprayed-dry extract of the herbal medicine used was purchased from Sun Ten pharmaceutical company in Taiwan. Each participant received twelve capsules of PM011, which divided into 2.4 g treatment or 4.8 g treatment group or placebo daily for two weeks and was instructed to take six capsules after breakfast and six capsules after dinner.
干预措施: PM011 (Dietary Supplement)
Placebo
Subjects in the placebo group received the equivalent amount of starch and lactose mixture capsules and administered with the same schedule.
干预措施: PM011 (Dietary Supplement)
结局指标
主要结局
Beck Depression Inventory (BDI)
时间窗: Change from baseline BDI score at 2 weeks
BDI is a 21 item, self rated inventory with each item rated with a set of four possible answer choices of increasing intensity.
Stress Response Inventory or Test (SRI or SRT)
时间窗: Change from baseline SRI or SRT score at 2 weeks
SRI is highly reliable and valid, and that it is utilized as an effective measure of stress for research in stress-related fields in Korea. SRI is a total of 39 response items under the seven subscales. The seven subscales are divided into tension (A), aggression (B), somatization (C), anger (D), depression (E), fatigue (F), and frustration (G). When the test is scored, a value of 0 to 4 is assigned for each answer and then the total score is compared to a key to determine the stress's severity.
次要结局
- Alpha/beta ratio of electroencephalogram (EEG)(Change from baseline Alpha/beta ratio of electroencephalogram (EEG) at 2 weeks)