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Study the Effect of Danggui Buxue Tang on Menopausal Symptoms

This study has been completed.
Information provided by:
Chinese University of Hong Kong Identifier:
First received: January 11, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
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.

Condition Intervention Phase
Drug: DBT-Danggui Buxue Tang
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • The Changes in severity and frequency of hot flushes and sweats.

Secondary Outcome Measures:
  • The Changes in score of the Menopause Specific Quality of Life and the values of various markers of risk for cardiovascular disease.

Estimated Enrollment: 100
Study Start Date: February 2003
Estimated Study Completion Date: December 2004

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00421564

Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Christopher J Haines, FPOGS Department of Obstetrics & Gynaecology, CUHK
  More Information

Publications: Identifier: NCT00421564     History of Changes
Other Study ID Numbers: ICM/CTS/004
Study First Received: January 11, 2007
Last Updated: January 11, 2007

Keywords provided by Chinese University of Hong Kong:
Traditional Chinese Medicine processed this record on April 27, 2017