Ignite Creation Date:
2024-05-05 @ 11:10 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01267539
Status:
COMPLETED
Last Update Posted:
2010-12-28
First Post:
2010-12-20
Brief Title:
Suan Tsao Jen Tang for Treating Menopause With Sleep Problem a Clinical Observation
Sponsor:
Taipei City Hospital
Organization:
Taipei City Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
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:
A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City HospitalClimacteric women with sleep difficulty received SZRT at a rate of 40 g thrice daily for four weeks
Detailed Description:
A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City Hospital between April 2008 and April 2010 Sixty-seven climacteric women with sleep difficulty received SZRT at a rate of 40 g thrice daily for four weeks Baseline scores were measured on the Pittsburg Sleep Quality Index PSQI followed by further measures at the end of weeks one and four The World Health Organization Quality of Life WHOQOL assessment and the Menopause Rating Scale MRS were undertaken as secondary outcomes Regression models were constructed to explore the score differences between the baseline and at weeks one and four by various determinants including age body mass index BMI and severity of baseline menopausal symptoms Among 99 surveyed patients 67 and 61 were screened for intention to treat ITT and per-protocol population set analysis respectively Statistically significant reductions in the PSQI index scores evidenced on the fourth week
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