Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275964
Status:
COMPLETED
Last Update Posted:
2008-10-24
First Post:
2006-01-11
Brief Title:
Development of Active Safety Surveillance System for Traditional Chinese Medicine
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-06
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:
ContextClinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have attracted peoples focus on the alternative therapy for menopausal symptoms This study drug- a mixture of CHIA-WEI-HSIAO-YAO-SAN CHIH-PO-TI-HUANG-WAN HSIANG-SHA-LIU-CHUN-TZU-TANG TMN1 is widely used as an alternative to hormonal therapies for hot flush in Taiwan However there is a paucity of data supporting their efficacy and safety
ObjectiveTo evaluate the safety and efficacy of TMN1 in the treatment of hot flush
Design and SettingA multi-center prospective observational follow-up study was conducted from July 2003 to December 2004 in 4 hospitals
ParticipantsIn total 136 eligible subjects entered this study They were required to take study drug 3 times a day for 12 weeks and make 9 visits at scheduled time for follow up efficacy and safety evaluations
Main Outcome MeasuresDuring the observation period the investigators and study nurses actively enquired subjects if there was any adverse event AEs occurring to them by using Traditional Chinese medicine Adverse Events TCM AE questionnaire which includes 20 AEs proposed by experienced CM doctors as most commonly seen in the use of study drug Every subjects complaint or abnormal laboratory value were carefully examined for possible causality and reviewed and decided by the research team The primary outcome measure was the mean changes from baseline to week 12 in terms of frequency of hot flush and the severity of menopausal symptoms measured by the Kupperman Menopause Index The secondary outcome measures included changes in quality of life measured by World Health Organization Quality of Life WHOQOL questionnaire and adverse events monitored actively by a global assessment of tolerability During the study period every subject also received tests on routine hematology biochemical function and gynecologically relevant hormones at baseline visit 4 weeks and 12 weeks after medication
ObjectiveTo evaluate the safety and efficacy of TMN1 in the treatment of hot flush
Design and SettingA multi-center prospective observational follow-up study was conducted from July 2003 to December 2004 in 4 hospitals
ParticipantsIn total 136 eligible subjects entered this study They were required to take study drug 3 times a day for 12 weeks and make 9 visits at scheduled time for follow up efficacy and safety evaluations
Main Outcome MeasuresDuring the observation period the investigators and study nurses actively enquired subjects if there was any adverse event AEs occurring to them by using Traditional Chinese medicine Adverse Events TCM AE questionnaire which includes 20 AEs proposed by experienced CM doctors as most commonly seen in the use of study drug Every subjects complaint or abnormal laboratory value were carefully examined for possible causality and reviewed and decided by the research team The primary outcome measure was the mean changes from baseline to week 12 in terms of frequency of hot flush and the severity of menopausal symptoms measured by the Kupperman Menopause Index The secondary outcome measures included changes in quality of life measured by World Health Organization Quality of Life WHOQOL questionnaire and adverse events monitored actively by a global assessment of tolerability During the study period every subject also received tests on routine hematology biochemical function and gynecologically relevant hormones at baseline visit 4 weeks and 12 weeks after medication
Detailed Description:
None
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