Status:
COMPLETED
Study the Effect of Danggui Buxue Tang on Menopausal Symptoms
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Menopause
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 i...
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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00421564
Start Date
February 1 2003
End Date
December 1 2004
Last Update
January 12 2007
Active Locations (1)
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1
Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital
Hong Kong, China