NCT00421564已完成2 期
A Randomized, Double-Blind, Placebo Controlled Study of the Effect of Danggui Buxue Tang on Menopausal Symptoms and Quality of Life in Hong Kong Chinese Women
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Changes in severity and frequency of hot flushes and sweats.
研究概览
简要总结
This study is to examine the effect and safety of the study drug,Danggui Buxue Tang, on menopausal symptoms of hot flushes and sweating and to determine whether the patient's quality of life will be improved.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Follicle stimulating hormone (FSH), luteinizing hormone (LH), oestradiol in the menopausal range (FSH>18 IU/L, LH>12.6 IU/L, and E2< 361 pmol/l).
- •Patients with amenorrhoea for more than 12 months
排除标准
- •Patients with a history of using any form of hormonal replacement therapy within 8 weeks
- •Patients with a history of using Chinese medicine or other therapies which may affect the outcome within 8 weeks
- •Patients who in the judgment of the investigator will be unable to comply with protocol requirements
- •Patients with significant** gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular, breast or endometrial carcinoma, or allergic diseases
- •Patients with uncontrolled hypertension
- •Patients with undiagnosed vaginal bleeding
- •Patients with a history of significant drug hypersensitivity
结局指标
主要结局
The Changes in severity and frequency of hot flushes and sweats.
次要结局
- The Changes in score of the Menopause Specific Quality of Life and the values of various markers of risk for cardiovascular disease.
研究者
研究点 (1)
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