Clinical trial NCT00420576: Dose Finding Study of Danggui Buxue Tang (Herbal Formula)on the Treatment of Menopausal Symptoms
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopausal
Keywords: Post-menopausal
Traditional Chinese Medicine
Randomized
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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
* 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

Primary outcomes:
measure: the changes in severity and frequency of hot flushes and sweats (menopausal symptoms)
timeFrame: 5 Months
Secondary outcomes:
measure: the changes of score on the Menopause specific quality of life
timeFrame: 5 Months
measure: the changes in values of various markers of risk for cardiovascular disease
timeFrame: 5 Months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital
Study officials:
affiliation: Department of Obstetrics & Gynaecology, CUHK
name: Christopher J Haines, FPOGS
role: PRINCIPAL_INVESTIGATOR
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