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| ID | Type | Description | Link |
|---|---|---|---|
| SHU-5366432 | Other Identifier | Shanghai University of TCM |
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| Name | Class |
|---|---|
| Longhua Hospital | OTHER |
| Shanghai Yueyang Integrated Medicine Hospital | OTHER |
| Shanghai Municipal Hospital of Traditional Chinese Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qing'E pills | Active Comparator | 9 g pills,twice a day for 12 weeks |
|
| Placebo | Placebo Comparator | 9 g pills,twice a day for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qing'E pills | Drug | composed of eucommia, psoralen, walnuts and garlic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hot flushes | Change in frequency of hot flushes from baseline to week 12. | 12 weeks |
| 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; |
| Measure | Description | Time Frame |
|---|---|---|
| Nerve-endocrine-immune (NEI) network profile | To evaluate the difference of NEI network expression from baseline to 12 weeks. The indices in NEI network include: Hypothalamic-pituitary-adrenal axis: CRH, ATCH, CORT; Hypothalamic-pituitary-thyroid axis: TRH, T3, T4; Renin - angiotensin - aldosterone system: PRA, Ang2, ALD; Sex hormones: E2, FSH; Immune factors: TNF-α、IL-6、IL-1; Cardiovascular indicators: ET, NO, Hcy, Folic acid |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qingshan Zheng, Doctor | Shanghai Universitu of TCM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 201108 | China |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Shanghai Putuo District Center Hospital |
| OTHER |
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| Placebo |
| Drug |
Containing 2% of Qing'E pills |
|
| 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 |
| 12 weeks |
| Urine metabolomics | 4 weeks, 8 weeks and 12 weeks |