Efficacy and Safety of Combined Treatment of Herbs and TCM Emotion Treatment for Women With Menopausal Syndrome: A Multiple-centered Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 8
- 主要终点
- Kupperman index
研究概览
简要总结
The purpose of this multiple-centered, randomized, controlled study is to investigate the efficacy and safety of a combination using herbs prescription and traditional Chinese medicine (TCM) emotion treatment in women with menopausal syndrome.
详细描述
Menopausal syndrome is a high incident disease which is associated with great influence in women's health and quality of life. It involves physical discomforts and emotional symptoms. Traditional Chinese medicine (TCM) theory emphasizes treating physical and emotional symptoms simultaneously viewing one person as an entirety. Herbs prescription and TCM emotion treatment is effective and safe to treat women with menopausal syndrome in clinical practice.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 41 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 41-60;
- •Amenorrhea for at least 6 months;
- •Menstruation dysfunction or cessation because of age or bilateral ovariectomy;
- •Hot flushes and night sweats symptoms;
- •Vaginal secretion decreased with or without dyspareunia;
- •Kupperman Index (KI) score ≥ 15;
- •Self-rating Anxiety Scale or Self-rating Depression Scale standard score >50,but <72(standard score= scale score ×1.25);
- •FSH ≥ 20 IU/L;
- •Thickness of endometrium ≤0.5cm if Amenorrhea for at least 12 months;or ≤1.5cm if Amenorrhea for 6 months to 12 months;
- •Meet the diagnosis criteria of TCM syndrome of liver stagnation and kidney deficiency.
排除标准
- •With malignant tumor in reproductive system;
- •With benign tumor in reproductive system and need surgery;
- •Malignant tumor in mammary gland;
- •Irregular vaginal bleeding for unknown reasons;
- •Thickness of endometrium ≥1.5cm by ultrasound examination;
- •Have used Sex hormone medicine or joined other clinical trials 3 months before;
- •Severe diseases (eg., of the cardiovascular, liver, kidney) or uncontrolled endocrine diseases (eg., diabetes mellitus, hyperthyreosis )
- •Severe psychiatric disease diagnosed by psychiatric physician;
- •Refuse informed consent.
研究组 & 干预措施
TCM intervention
Particle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone
干预措施: TCM intervention (Other)
Western intervention
Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs
干预措施: Western intervention (Other)
结局指标
主要结局
Kupperman index
时间窗: 2 months
次要结局
- blood serum estradiol(2 months)