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NCT00421564 Clinical Trial

Study the Effect of Danggui Buxue Tang on Menopausal Symptoms

Menopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00421564
Other study ID # ICM/CTS/004
Secondary ID
Status Completed
Phase Phase 2
First received January 11, 2007
Last updated January 11, 2007
Start date February 2003
Est. completion date December 2004

Study information
Verified date January 2007
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• DBT-Danggui Buxue Tang

Locations
Country Name City State
China Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (9)

Au GK. Evaluation of the benefits and risks of hormone replacement therapy. Hong Kong Med J. 2000 Dec;6(4):381-9. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Fugh-Berman A. Herb-drug interactions. Lancet. 2000 Jan 8;355(9198):134-8. Review. Erratum in: Lancet 2000 Mar 18;355(9208):1020. — View Citation

Hagstad A, Janson PO. The epidemiology of climacteric symptoms. Acta Obstet Gynecol Scand Suppl. 1986;134:59-65. — View Citation

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. — View Citation

Schneider HP, Gallagher JC. Moderation of the daily dose of HRT: benefits for patients. Maturitas. 1999 Nov;33 Suppl 1:S25-9. — View Citation

Zhu DP. Dong quai. Am J Chin Med. 1987;15(3-4):117-25. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The Changes in severity and frequency of hot flushes and sweats.
Secondary 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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