Clinical trial NCT00421564: Study the Effect of Danggui Buxue Tang on Menopausal Symptoms
Official title: A Randomized, Double-Blind, Placebo Controlled Study of the Effect of Danggui Buxue Tang on Menopausal Symptoms and Quality of Life in Hong Kong Chinese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Menopause
Keywords: Menopausal
Traditional Chinese Medicine
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2007-01-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Changes in severity and frequency of hot flushes and sweats.
Secondary outcomes:
measure: The Changes in score of the Menopause Specific Quality of Life and the values of various markers of risk for cardiovascular disease.
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital
Study officials:
affiliation: Department of Obstetrics & Gynaecology, CUHK
name: Christopher J Haines, FPOGS
role: PRINCIPAL_INVESTIGATOR
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