Study the Effect of Danggui Buxue Tang on Menopausal Symptoms - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

MedlinePlus related topics: Menopause Sweat

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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

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

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.

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.

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

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.

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.

ClinicalTrials.gov Identifier:	NCT00421564 History of Changes
Other Study ID Numbers:	ICM/CTS/004
Study First Received:	January 11, 2007
Last Updated:	January 11, 2007
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:

Menopausal
Traditional Chinese Medicine

ClinicalTrials.gov processed this record on May 23, 2013