Menopause
Conditions
Keywords
Menopausal, Traditional Chinese Medicine
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.
Interventions
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Changes in severity and frequency of hot flushes and sweats. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Changes in score of the Menopause Specific Quality of Life and the values of various markers of risk for cardiovascular disease. | — |
Countries
China
Outcome results
None listed