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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00420576 |
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.
Condition | Intervention | Phase |
---|---|---|
Postmenopausal |
Drug: DBT-Danggui Buxue Tang |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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) |
Enrollment: | 60 |
Study Start Date: | June 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Low Dose Danggui Buxue Tang (1.5g)
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Drug: 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
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2: Experimental
Middle Dose Danggui Buxue Tang(3g)
|
Drug: 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
|
3: Experimental
High Dose Danggui Buxue Tang (6g)
|
Drug: 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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital | |
Hong Kong, China |
Principal Investigator: | Christopher J Haines, FPOGS | Department of Obstetrics & Gynaecology, CUHK |
Responsible Party: | The Chinese University of Hong Kong ( The Institute of Chinese Medicine ) |
Study ID Numbers: | ICM/CTS/05/336 |
Study First Received: | January 9, 2007 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00420576 History of Changes |
Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Post-menopausal Traditional Chinese Medicine Randomized |
Signs and Symptoms Dong Quai Astragalus Menopause |