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

Study Overview
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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.

Official Title
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A Randomized, Double-Blind, Multiple-Dose Escalation Study of the Effect of Danggui Buxue Tang on Symptomatic Postmenopausal Hong Kong Chinese Women (Continuation of a Completed Study Using the Same Formula)

Conditions
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Postmenopausal

Intervention / Treatment
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* Drug: DBT-Danggui Buxue Tang


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low Dose Danggui Buxue Tang (1.5g) | Drug: DBT-Danggui Buxue Tang<br>* 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<br>* Other names: Danggui Buxue Tang;|
| Experimental: 2<br>Middle Dose Danggui Buxue Tang(3g) | Drug: DBT-Danggui Buxue Tang<br>* 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<br>* Other names: Danggui Buxue Tang;|
| Experimental: 3<br>High Dose Danggui Buxue Tang (6g) | Drug: DBT-Danggui Buxue Tang<br>* 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<br>* Other names: Danggui Buxue Tang;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes in severity and frequency of hot flushes and sweats (menopausal symptoms) |  | 5 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of score on the Menopause specific quality of life |  | 5 Months | 
| the changes in values of various markers of risk for cardiovascular disease |  | 5 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-menopausal, Traditional Chinese Medicine, Randomized