Study the Effect of Danggui Buxue Tang on Menopausal Symptoms
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Outcome Measures
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. []
Eligibility Criteria
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).
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Patients with amenorrhoea for more than 12 months
Exclusion Criteria:
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Patients with a history of using any form of hormonal replacement therapy within 8 weeks
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Patients with a history of using Chinese medicine or other therapies which may affect the outcome within 8 weeks
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Patients who in the judgment of the investigator will be unable to comply with protocol requirements
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Patients with significant** gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular, breast or endometrial carcinoma, or allergic diseases
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Patients with uncontrolled hypertension
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Patients with undiagnosed vaginal bleeding
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Patients with a history of significant drug hypersensitivity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Au GK. Evaluation of the benefits and risks of hormone replacement therapy. Hong Kong Med J. 2000 Dec;6(4):381-9. Review.
- 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.
- 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.
- 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.
- Fugh-Berman A. Herb-drug interactions. Lancet. 2000 Jan 8;355(9198):134-8. Review. Erratum in: Lancet 2000 Mar 18;355(9208):1020.
- Hagstad A, Janson PO. The epidemiology of climacteric symptoms. Acta Obstet Gynecol Scand Suppl. 1986;134:59-65.
- 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.
- Schneider HP, Gallagher JC. Moderation of the daily dose of HRT: benefits for patients. Maturitas. 1999 Nov;33 Suppl 1:S25-9.
- Zhu DP. Dong quai. Am J Chin Med. 1987;15(3-4):117-25.
- ICM/CTS/004