Postmenopausal Clinical Trial
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)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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