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Completed

NCT Number: NCT01267539

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

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.

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Key information

Age range

40 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Taipei City Hospital

Taipei, Taiwan, 111

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Collaborators

  • Chinese Medical Association

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 28, 2010
Registry last updated
Dec 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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