Clinical trial NCT01267539: Suan Tsao Jen Tang for Treating Menopause With Sleep Problem: a Clinical Observation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopausal and Female Climacteric States
Keywords: Suan Zao Ren Tang, climacteric, PSQI, WHOQOL-BREF
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Chinese Medical Association
First posted: 2010-12-28
Enrollment: 67
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
affiliation: Taipei City Hospital
name: Jung-Nien Lai, PHD
role: STUDY_CHAIR
References: