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

NCT ID: NCT01267539

Last Updated: 2010-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Menopausal and Female Climacteric States

Keywords

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Suan Zao Ren Tang, climacteric, PSQI, WHOQOL-BREF

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese Medical Association

NETWORK

Sponsor Role collaborator

Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Taipei City Hospital

Principal Investigators

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Jung-Nien Lai, PHD

Role: STUDY_CHAIR

Taipei City Hospital

Locations

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Taipei City Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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TCHIRB-970110-E

Identifier Type: -

Identifier Source: org_study_id