Qing'E Formula Therapy on Menopausal Symptoms

Study Overview
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Brief Summary
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The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is effective in alleviating menopausal symptoms and safety.

Detailed Description
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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.

Official Title
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A Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial on the Effects of Chinese Medicine Formula (Qing'E) on Menopausal Symptoms

Conditions
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Menopause

Intervention / Treatment
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* Drug: Qing'E pills
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Qing'E pills<br>9 g pills,twice a day for 12 weeks | Drug: Qing'E pills<br>* composed of eucommia, psoralen, walnuts and garlic<br>|
| Placebo Comparator: Placebo<br>9 g pills,twice a day for 12 weeks | Drug: Placebo<br>* Containing 2% of Qing'E pills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flushes | Change in frequency of hot flushes from baseline to week 12. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flushes | Change in frequency of hot flushes from baseline to week 4 and week 8. | 4 weeks, 8 weeks | 
| Hot flushes | Decline rate of hot flushes from baseline to week 4, week 8 and week 12; | 4 weeks, 8 weeks and 12 weeks | 
| Mean differences of Kupperman index | To calculate the Kupperman index, the symptoms were weighted as follows: hot flashes (4), insomnia (2), nervousness (2), and all other symptoms (night sweats, depressed mood (melancholy), dizziness, tiredness, joint and muscular pain, headache, and palpitations (1). The highest potential score is thus 51. The score of hot flashes was based on number of complaints per day: slight (more than 5), moderate (5-10), and severe (more than 10) | 4 weeks, 8 weeks and 12 weeks | 
| Mean difference of single clinical symptom in Kupperman index |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopausal syndrome, climacteric syndrome, Hot flashes, Sweat