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.

Study Overview

• Status: Completed
• Conditions: Menopausal and Female Climacteric States

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.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 111
    • Taipei City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Collaborators: Chinese Medical Association
• Investigators: Study Chair: Jung-Nien Lai, PHD, Taipei City Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: December 27, 2010
• First Posted (Estimate): December 28, 2010

Study Record Updates

• Last Update Posted (Estimate): December 28, 2010
• Last Update Submitted That Met QC Criteria: December 27, 2010
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Suan Zao Ren Tang, climacteric, PSQI, WHOQOL-BREF
• Other Study ID Numbers: TCHIRB-970110-E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No