Study the Effect of Danggui Buxue Tang on Menopausal Symptoms

NCT ID: NCT00421564

Last Updated: 2007-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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DBT-Danggui Buxue Tang

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Principal Investigators

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Christopher J Haines, FPOGS

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics & Gynaecology, CUHK

Locations

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Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital

Hong Kong, , China

Site Status

Countries

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China

References

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Hagstad A, Janson PO. The epidemiology of climacteric symptoms. Acta Obstet Gynecol Scand Suppl. 1986;134:59-65. doi: 10.3109/00016348609157052.

Reference Type BACKGROUND
PMID: 3468732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10661612 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11177160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10687878 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9571599 (View on PubMed)

Zhu DP. Dong quai. Am J Chin Med. 1987;15(3-4):117-25. doi: 10.1142/S0192415X87000151.

Reference Type BACKGROUND
PMID: 3425569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11245505 (View on PubMed)

Fugh-Berman A. Herb-drug interactions. Lancet. 2000 Jan 8;355(9198):134-8. doi: 10.1016/S0140-6736(99)06457-0.

Reference Type BACKGROUND
PMID: 10675182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8905602 (View on PubMed)

Other Identifiers

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ICM/CTS/004

Identifier Type: -

Identifier Source: org_study_id

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