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

Menopausal and Female Climacteric States Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267539
• Other study ID #: TCHIRB-970110-E
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: December 27, 2010
• Start date: April 2008
• Est. completion date: April 2010

Study information

• Verified date: January 2008
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Menopausal and Female Climacteric States

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei City Hospital	Chinese Medical Association

Country where clinical trial is conducted

Taiwan,