Study the Effect of Danggui Buxue Tang on Menopausal Symptoms

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00421564
First received: January 11, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 11, 2007
January 11, 2007
February 2003
Not Provided
The Changes in severity and frequency of hot flushes and sweats.
Same as current
No Changes Posted
The Changes in score of the Menopause Specific Quality of Life and the values of various markers of risk for cardiovascular disease.
Same as current
Not Provided
Not Provided
 
Study the Effect of Danggui Buxue Tang on Menopausal Symptoms
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Menopause
Drug: DBT-Danggui Buxue Tang
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2004
Not Provided

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00421564
ICM/CTS/004
Not Provided
Not Provided
Chinese University of Hong Kong
Not Provided
Principal Investigator: Christopher J Haines, FPOGS Department of Obstetrics & Gynaecology, CUHK
Chinese University of Hong Kong
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP