CClinicalTrials.gg
CompletedNCT01267539Updated Dec 28, 2010

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

An observational study in Menopausal and Female Climacteric States, sponsored by Taipei City Hospital. Completed at 1 site in Taiwan. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-12-28.

Sponsored by Taipei City Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
67
Ages
40 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Menopausal and Female Climacteric States

Keywords

  • Suan Zao Ren Tang, climacteric, PSQI, WHOQOL-BREF
03

In context

Lead sponsor

Taipei City Hospital is the lead sponsor of 56 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
67 participants (actual)
06

Study locations

1 site
  • Taipei City Hospital
    Taipei, 111, Taiwan
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01267539
Lead sponsor
Taipei City Hospital
Collaborators
Chinese Medical Association
First posted
Dec 28, 2010
Start date
Apr 2008
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Dec 28, 2010

Study contacts

Jung-Nien Lai, PHD
study chair · Taipei City Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion