A Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial on the Effects of Chinese Medicine Formula (Qing'E) on Menopausal Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Hot flushes
研究概览
简要总结
The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is effective in alleviating menopausal symptoms and safety.
详细描述
This is a double-blind placebo-controlled randomized clinical trial to evaluate whether a Chinese medicine formula (Qing'E, composed of eucommia, psoralen, walnuts and garlic) is effective in alleviating menopausal symptoms. 240 Chinese women with menopausal symptoms will be recruited and randomized into two groups. One is treatment group with 12 weeks of Qing'E pills (well-controlled), the other is controlled group with 12 weeks of placebo. The treatment outcome measures include: 1) the severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes), the Kupperman index. 2) NEI network indices. 3) Urine metabolomics. All measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms, Kupperman index and urine metabolomics. Tyhe investigators expect this research will provide an effective and safe therapy for menopausal symptoms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months.
- •Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours.
- •Patients unused estrogen tablets or progesterone injection in 6 months.
- •Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
- •Get subjects informed consent process should comply with GCP requirements.
排除标准
- •Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g / L).
- •Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
- •Allergic constitution and known allergy to the drug.
- •Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
- •Patients with hyperthyroidism, coronary atheroma, diabetes, obesity (body mass index of more than 30 kg/m2), migraine, malignant tumors, thromboembolic disease, gastrointestinal diseases affect absorption or autoimmune diseases.
- •Alcoholics or smokers (past or smoking).
- •Patients are participating in other clinical trials.
研究组 & 干预措施
Qing'E pills
9 g pills,twice a day for 12 weeks
干预措施: Qing'E pills (Drug)
Placebo
9 g pills,twice a day for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Hot flushes
时间窗: 12 weeks
Change in frequency of hot flushes from baseline to week 12.
次要结局
- Hot flushes(4 weeks, 8 weeks and 12 weeks)
- Mean differences of Kupperman index(4 weeks, 8 weeks and 12 weeks)
- Mean difference of single clinical symptom in Kupperman index(12 weeks)