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Symptoms of anxiety are prevalent during the menopausal transition and early postmenopause. These symptoms are mainly improved by anti-anxiety agents, which are associated with some adverse effects including dizziness, sleepiness, and constipation and not all patients respond to currently available pharmacological treatments, thus novel agents with fewer side effects are needed. Some studies have shown that traditional Chinese medicine can alleviate menopausal symptoms safely and economically, and improve quality of life. Xiangshao granules reportedly have good curative effects on menopausal symptoms and premenstrual syndrome and exhibit good safety. This study aim to evaluate the efficacy and safety of Xiangshao granule in improving anxiety state of women with menopause syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xiangshao Granules | Experimental | dissolve 1 sachet (4 g) of Xiangshao Granules in water to be drank 3 times a day after meal for 8 weeks |
|
| Xiangshao Granules Placebo | Placebo Comparator | dissolve 1 sachet (4 g) of Xiangshao Granules placebo in water to be drank 3 times a day after meal for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiangshao Granules | Drug | dissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-rating Anxiety Scale (SAS) scores change (%) | % change in SAS scores after 8 weeks of treatment compared with baseline scores | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SAS scores change (%) | % change in SAS scores after 4 weeks of treatment compared with baseline scores | 4 weeks |
| Kupperman scores change (%) | % change in Kupperman scores after 4 weeks of treatment compared with baseline scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rong Chen | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Province Maternity & Child Health Hospital | Hefei | Anhui | China | |||
| Peking Union Medical College Hospital |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Xiangshao Granules Placebo | Drug | Xiangshao Granules Placebo |
|
| 4 weeks |
| Kupperman scores change (%) | % change in Kupperman scores after 8 weeks of treatment compared with baseline scores | 8 weeks |
| Self-rating Depression Scale (SDS) scores change (%) | % change in SDS scores after 4 weeks of treatment compared with baseline scores | 4 weeks |
| SDS scores change (%) | % change in SDS scores after 8 weeks of treatment compared with baseline scores | 8 weeks |
| serum Follicle Stimulating Hormone (FSH) level | change in serum FSH level after 4 weeks of treatment compared with baseline | 4 weeks |
| serum FSH level | change in serum FSH level after 8 weeks of treatment compared with baseline | 8 weeks |
| serum estradiol (E2) level | change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline | 4 weeks |
| serum estradiol (E2) level | change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline | 8 weeks |
| gastrointestinal symptom score (GIS) change (%) | % change in GIS after 4 weeks of treatment compared with baseline scores | 4 weeks |
| gastrointestinal symptom score (GIS) change (%) | % change in GIS after 8 weeks of treatment compared with baseline scores | 8 weeks |
| Beijing |
| Beijing Municipality |
| 010 |
| China |
| Chongqing Health Center for Women and Children | Chongqing | Chongqing Municipality | China |
| Gansu Provincial Maternity and Child-care Hospital | Lanzhou | Gansu | China |
| Cangzhou People's Hospital | Cangzhou | Hebei | China |
| Second Hospital of Hebei Medical University | Shijiangzhuang | Hebei | China |
| The First Affiliated Hospital of Henan University | Kaifeng | Henan | China |
| Zhengzhou Central Hospital Affiliated to Zhengzhou University | Zhengzhou | Henan | China |
| Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Jiangsu Province Hospital of Chinese Medicine | Nanjing | Jiangsu | China |
| Taizhou People's Hospital | Taizhou | Jiangsu | China |
| Zhangjiagang First People's Hospital | Zhangjiagang | Jiangsu | 0512 | China |
| Jiangxi Maternal and Child Health Hospital | Nanchang | Jiangxi | China |
| Affiliated Zhongshan Hospital of Dalian University | Dalian | Liaoning | China |
| Liaocheng People's Hospital | Liaocheng | Shandong | China |
| Chengdu Women's and Children's Central Hospital | Chengdu | Sichuan | China |
| School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College | Chengdu | Sichuan | China |
| Tianjin Hospital of ITCWM Nankai Hospital | Tianjin | Tianjin Municipality | China |