Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Combined Treatment of Herbs and TCM Emotion Treatment for Women With Menopausal Syndrome: A Multiple-centered Randomized Controlled Trial

Conditions
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Menopausal Syndrome

Intervention / Treatment
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* Other: TCM intervention
* Other: Western intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; Allergy; 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.

Ages Eligible for Study
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Minimum Age: 41 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCM intervention<br>Particle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone | Other: TCM intervention<br>* Drug: Particle of compound Chinese herbs(produced by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months. One tablet placebo of Tibolone (provided by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China, once every two days, taken orally, for two months. Behavioral: TCM emotion treatment: made under the guide of TCM theory, administered by qualified TCM physician, for three times in two months.<br>|
| Active Comparator: Western intervention<br>Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs | Other: Western intervention<br>* Drug: Tibolone, (produced by Oujianong corporation, Nanjing, China), 2.5mg, once every two days, taken orally, for two months; Particle placebo of compound Chinese herbs (produced by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months. Behavioral: supportive psychotherapy, administered by qualified physician, for three times in two months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kupperman index |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood serum estradiol |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopausal syndrome, TCM intervention