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Study the Effect of Danggui Buxue Tang on Menopausal Symptoms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00421564
First Posted: January 12, 2007
Last Update Posted: January 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chinese University of Hong Kong
  Purpose
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
Menopause Drug: DBT-Danggui Buxue Tang Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421564


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

Publications:
ClinicalTrials.gov Identifier: NCT00421564     History of Changes
Other Study ID Numbers: ICM/CTS/004
First Submitted: January 11, 2007
First Posted: January 12, 2007
Last Update Posted: January 12, 2007
Last Verified: January 2007

Keywords provided by Chinese University of Hong Kong:
Menopausal
Traditional Chinese Medicine