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

This study has been completed.
Sponsor:
Collaborator:
Chinese Medical Association
Information provided by:
Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT01267539
First received: December 20, 2010
Last updated: December 27, 2010
Last verified: January 2008

December 20, 2010
December 27, 2010
April 2008
April 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01267539 on ClinicalTrials.gov Archive Site
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Suan Tsao Jen Tang for Treating Menopause With Sleep Problem: a Clinical Observation
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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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

Menopausal and Female Climacteric States
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Female
40 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01267539
TCHIRB-970110-E
Yes
Jung-Lien Lai/Taipei City Hospital, Taipei City Hospital
Taipei City Hospital
Chinese Medical Association
Study Chair: Jung-Nien Lai, PHD Taipei City Hospital
Taipei City Hospital
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP