Suan Tsao Jen Tang for Treating Menopause With Sleep Prob... | NCT01267539

Studies
Suan Tsao Jen Tang for Treating Menopause With Sleep Problem: a Clinical Observation

NCT01267539

Sponsor

Taipei City Hospital

Status

Completed

Last Update Posted

Dec 28, 2010Estimated

Enrollment

67Actual

Phase

Not provided

Conditions

Menopausal and Female Climacteric States

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Dec 20, 2010

First Submission Date that Met QC Criteria

Dec 27, 2010

First Posted Date

Dec 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2010

Last Update Posted Date

Dec 28, 2010Estimated

Name	Class
Chinese Medical Association	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City Hospital.Climacteric women with sleep difficulty received SZRT at a rate of 4.0 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 4.0 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Climacteric women, ranging from 40-65 years of age
Pittsburg Sleep Quality Index (PSQI) of greater than six
Falling asleep more than 45 minutes or slept less than six hours

Exclusion Criteria:

Within three months of the study there had been a major incident
Working the nightshift
Lack of time or timing conflicts
Pychosis, severe depression, obstructive sleep apnea-hypopnea, cardiac arrhythmia, acute myocardial infarction, high blood pressure, diabetes, or cancer
Currently taking pharmaceuticals that affect melatonin, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, or prostaglandins
Inability to read and fill out the forms for the study
Any evidence of renal or liver dysfunction as defined by a level of at least 1.5 times of the upper reference limit

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

The subjects enrolled in the study were climacteric women, ranging from 40-65 years of age, with a Pittsburg Sleep Quality Index (PSQI) of greater than six. These women spent 45 minutes or more falling asleep, slept less than six hours, and had struggled with this issue continuously for at least one month.

Sampling Method

Non-Probability Sample