Study the Effect of Danggui Buxue Tang on Menopausal Symptoms
Phase 2
Completed
- Conditions
- Menopause
- Registration Number
- NCT00421564
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
This study is to examine the effect and safety of the study drug,Danggui Buxue Tang, on menopausal symptoms of hot flushes and sweating and to determine whether the patient's quality of life will be improved.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
- Follicle stimulating hormone (FSH), luteinizing hormone (LH), oestradiol in the menopausal range (FSH>18 IU/L, LH>12.6 IU/L, and E2< 361 pmol/l).
- Patients with amenorrhoea for more than 12 months
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Exclusion Criteria
- Patients with a history of using any form of hormonal replacement therapy within 8 weeks
- Patients with a history of using Chinese medicine or other therapies which may affect the outcome within 8 weeks
- Patients who in the judgment of the investigator will be unable to comply with protocol requirements
- Patients with significant** gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular, breast or endometrial carcinoma, or allergic diseases
- Patients with uncontrolled hypertension
- Patients with undiagnosed vaginal bleeding
- Patients with a history of significant drug hypersensitivity
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The Changes in severity and frequency of hot flushes and sweats.
- Secondary Outcome Measures
Name Time Method The Changes in score of the Menopause Specific Quality of Life and the values of various markers of risk for cardiovascular disease.
Trial Locations
- Locations (1)
Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital
🇨🇳Hong Kong, China