Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420576
Status:
COMPLETED
Last Update Posted:
2008-12-18
First Post:
2007-01-09
Brief Title:
Dose Finding Study of Danggui Buxue Tang Herbal Formulaon the Treatment of Menopausal Symptoms
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-2002152-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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None