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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
NameTimeMethod
The Changes in severity and frequency of hot flushes and sweats.
Secondary Outcome Measures
NameTimeMethod
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

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