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Dose Finding Study of Danggui Buxue Tang (Herbal Formula)on the Treatment of Menopausal Symptoms

NCT ID: NCT00420576

Last Updated: 2008-12-18

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-12-31

Brief Summary

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Main purpose of the study is to look for an optimal dose for the treatment of menopausal symptoms with the Chinese Herbal Medicines containing Dang Gui and Huang Qi.

Detailed Description

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The menopause implies the permanent cessation of menstrual bleeding. In western medicine, this is associated either with the spontaneous failure of normal ovarian function, or it may also result from surgical removal of the ovaries or as a consequence of chemotherapy or radiotherapy. In western medicine, the usual treatment of the menopause is the use of oestrogen replacement therapy. However, treatment with oestrogen may result in unwanted side effects such as breast soreness and nausea. In addition, the long-term safety of oestrogen treatment has not been established. Oestrogen is therefore a valuable treatment for the menopause, but it is not without side effects. It remains to be seen whether Chinese Medicine as described in this proposal can prove to be an effective, safe and well tolerated treatment for the menopause. Dang Gui (Radix Angelicae Sinensis) is one Chinese herb that is recommended for the treatment of menopausal symptoms. Huang Qi is also used in the treatment of the menopausal symptoms to tonify Qi. We have now shown a beneficial effect of Danggui Buxue Tang on vasomotor symptoms in postmenopausal Chinese women (Re: CREC Ref. No. CRE-2002.152-T). However, we could not show a difference in the reduction in severity of symptoms between Danggui Buxue Tang and placebo. We now wish to confirm our initial findings, and we hope to obtain more reliable data by (1) only including women who have never used any type of treatment for their menopause and (2) by recruiting women who have more severe symptoms of the menopause.

Chinese Herbal Medicines containing Dang Gui and Huang Qi have been used for many years to treat menopausal women. There are few data on possible adverse effects of treatment with Chinese Herbal Medicine containing Dang Gui as well as Huang Qi..

The objective of present study is to investigate the dose response relationship to assess an optimal dose suitable for clinical use. The trial will be designed as a multiple-dose escalation clinical trial to obtain accurate information on the efficacy and safety when used for menopausal women. Since previous study has already confirmed that the dose used was efficacious, the main purpose of the study is to look for an optimal dose for the treatment of menopausal symptoms.

Conditions

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Postmenopausal

Keywords

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Post-menopausal Traditional Chinese Medicine Randomized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Low Dose Danggui Buxue Tang (1.5g)

Group Type EXPERIMENTAL

DBT-Danggui Buxue Tang

Intervention Type DRUG

Herbal Combination of Danggui (Radix Angelicae Sinensis) and Huangqi (Radix Astragali)in granules form, in 3 different dosage 6g/3g/1.5g, once time per day for 3 Months treatment

2

Middle Dose Danggui Buxue Tang(3g)

Group Type EXPERIMENTAL

DBT-Danggui Buxue Tang

Intervention Type DRUG

Herbal Combination of Danggui (Radix Angelicae Sinensis) and Huangqi (Radix Astragali)in granules form, in 3 different dosage 6g/3g/1.5g, once time per day for 3 Months treatment

3

High Dose Danggui Buxue Tang (6g)

Group Type EXPERIMENTAL

DBT-Danggui Buxue Tang

Intervention Type DRUG

Herbal Combination of Danggui (Radix Angelicae Sinensis) and Huangqi (Radix Astragali)in granules form, in 3 different dosage 6g/3g/1.5g, once time per day for 3 Months treatment

Interventions

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DBT-Danggui Buxue Tang

Herbal Combination of Danggui (Radix Angelicae Sinensis) and Huangqi (Radix Astragali)in granules form, in 3 different dosage 6g/3g/1.5g, once time per day for 3 Months treatment

Intervention Type DRUG

Other Intervention Names

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Danggui Buxue Tang

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
* Never received treatment for menopausal symptoms
* Never received menopausal hormone therapy
* Reporting a minimum of 21 hot flushes per week at the time of entry into the study

Exclusion Criteria

* 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
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

Responsible Party

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The Chinese University of Hong Kong

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/05/336

Identifier Type: -

Identifier Source: org_study_id