Study the Effect of Danggui Buxue Tang on Menopausal Symptoms
January 11, 2007 updated by: Chinese University of Hong Kong
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.
Study Overview
Study Type
Interventional
Enrollment
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, China
- Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The Changes in severity and frequency of hot flushes and sweats.
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Secondary Outcome Measures
Outcome Measure |
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The Changes in score of the Menopause Specific Quality of Life and the values of various markers of risk for cardiovascular disease.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hagstad A, Janson PO. The epidemiology of climacteric symptoms. Acta Obstet Gynecol Scand Suppl. 1986;134:59-65. doi: 10.3109/00016348609157052.
- Schneider HP, Gallagher JC. Moderation of the daily dose of HRT: benefits for patients. Maturitas. 1999 Nov;33 Suppl 1:S25-9. doi: 10.1016/s0378-5122(99)00060-2.
- Au GK. Evaluation of the benefits and risks of hormone replacement therapy. Hong Kong Med J. 2000 Dec;6(4):381-9.
- Blumel JE, Castelo-Branco C, Binfa L, Gramegna G, Tacla X, Aracena B, Cumsille MA, Sanjuan A. Quality of life after the menopause: a population study. Maturitas. 2000 Jan 15;34(1):17-23. doi: 10.1016/s0378-5122(99)00081-x.
- Hall G, Pripp U, Schenck-Gustafsson K, Landgren BM. Long-term effects of hormone replacement therapy on symptoms of angina pectoris, quality of life and compliance in women with coronary artery disease. Maturitas. 1998 Jan 12;28(3):235-42. doi: 10.1016/s0378-5122(97)00080-7.
- Zhu DP. Dong quai. Am J Chin Med. 1987;15(3-4):117-25. doi: 10.1142/S0192415X87000151.
- Davis SR, Briganti EM, Chen RQ, Dalais FS, Bailey M, Burger HG. The effects of Chinese medicinal herbs on postmenopausal vasomotor symptoms of Australian women. A randomised controlled trial. Med J Aust. 2001 Jan 15;174(2):68-71. doi: 10.5694/j.1326-5377.2001.tb143156.x.
- Fugh-Berman A. Herb-drug interactions. Lancet. 2000 Jan 8;355(9198):134-8. doi: 10.1016/S0140-6736(99)06457-0. Erratum In: Lancet 2000 Mar 18;355(9208):1020.
- Chung TK, Yip SK, Lam P, Chang AM, Haines CJ. A randomized, double-blind, placebo-controlled, crossover study on the effect of oral oestradiol on acute menopausal symptoms. Maturitas. 1996 Oct;25(2):115-23. doi: 10.1016/0378-5122(96)01050-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Study Completion
December 1, 2004
Study Registration Dates
First Submitted
January 11, 2007
First Submitted That Met QC Criteria
January 11, 2007
First Posted (ESTIMATE)
January 12, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
January 12, 2007
Last Update Submitted That Met QC Criteria
January 11, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ICM/CTS/004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.