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| ID | Type | Description | Link |
|---|---|---|---|
| 2007BAI20B014 | Other Identifier | State Administration of TCM of China |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM intervention | Experimental | Particle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone |
|
| Western intervention | Active Comparator | Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCM intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Kupperman index | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| blood serum estradiol | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoyun Wang, Bachelor | Guangzhou University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foshan Hospital of Traditional Chinese Medicine | Foshan | Guangdong | 528000 | China | ||
| Guangzhou University of Traditional Chinese Medicine |
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| Western intervention | Other | 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. |
|
| Guangzhou |
| Guangdong |
| 510120 |
| China |
| Liwan Hospital of Traditional Chinese Medicine | Guangzhou | Guangdong | 510360 | China |
| Affiliated Hospital of Hubei College of Traditional Chinese Medicine | Wuhan | Hubei | 430061 | China |
| Affiliated Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan | 610075 | China |
| Affiliated Hospital of Wenzhou Medical College | Wenzhou | Zhejiang | 325000 | China |
| Longhua Hospital of Shanghai University of Traditional Chinese Medicine | Shanghai | 200032 | China |
| Baokang Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | 300170 | China |