Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284492
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2006-01-30
Brief Title:
Acupuncture for Hot Flushes in Menopause
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Effectiveness of Acupuncture-care for Treatment of Hot Flushes Among Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2012-05
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:
ACUFLASH
Brief Summary:
In a pragmatic study investigate whether Traditional Chinese Medicine acupuncture-care decreases the frequency of hot flushes and increases health related quality of life among postmenopausal women The intervention group will receive 10 sessions of acupuncture the control group will engage in self care only The study period lasts for 12 weeks
Detailed Description:
The study objective is to determine whether Traditional Chinese Medicine TCM acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints among women who seek alternatives to hormonal replacement therapy HRT Study design is a pragmatic randomised controlled trial with two parallel arms Study participants are postmenopausal women who document a mean value of 7 flushes24 hours and who are not using HRT or other prescribed medication that may influence climacteric complaints The treatment group will receive 10 sessions of TCM acupuncture-care and self-care the control group will engage in self-care only
The duration of intervention period is 12 weeks with evaluations at baseline 4 8 12 weeks and follow up at 6 and 12 months after baseline Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks secondary endpoint is health related quality of life N in each treatment group 143 286 altogether
The duration of intervention period is 12 weeks with evaluations at baseline 4 8 12 weeks and follow up at 6 and 12 months after baseline Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks secondary endpoint is health related quality of life N in each treatment group 143 286 altogether
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