Status:
COMPLETED
Dose Finding Study of Danggui Buxue Tang (Herbal Formula)on the Treatment of Menopausal Symptoms
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Postmenopausal
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Main purpose of the study is to look for an optimal dose for the treatment of menopausal symptoms with the Chinese Herbal Medicines containing Dang Gui and Huang Qi.
Detailed Description
The menopause implies the permanent cessation of menstrual bleeding. In western medicine, this is associated either with the spontaneous failure of normal ovarian function, or it may also result from ...
Eligibility Criteria
Inclusion
- 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
- Never received treatment for menopausal symptoms
- Never received menopausal hormone therapy
- Reporting a minimum of 21 hot flushes per week at the time of entry into the study
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00420576
Start Date
June 1 2006
End Date
December 1 2007
Last Update
December 18 2008
Active Locations (1)
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1
Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital
Hong Kong, China