Suan Tsao Jen Tang for Treating Menopause With Sleep Problem: a Clinical Observation
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Purpose
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.
| Condition |
|---|
|
Menopausal and Female Climacteric States |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Enrollment: | 67 |
| Study Start Date: | April 2008 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jung-Lien Lai/Taipei City Hospital, Taipei City Hospital |
| ClinicalTrials.gov Identifier: | NCT01267539 History of Changes |
| Other Study ID Numbers: | TCHIRB-970110-E |
| Study First Received: | December 20, 2010 |
| Last Updated: | December 27, 2010 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Taipei City Hospital:
|
Suan Zao Ren Tang, climacteric, PSQI, WHOQOL-BREF |
ClinicalTrials.gov processed this record on May 23, 2013