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

This study has been completed.
Sponsor:
Collaborator:
Chinese Medical Association
Information provided by:
Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT01267539
First received: December 20, 2010
Last updated: December 27, 2010
Last verified: January 2008
  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

Resource links provided by NLM:


Further study details as provided by Taipei City Hospital:

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)
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

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267539

Locations
Taiwan
Taipei City Hospital
Taipei, Taiwan, 111
Sponsors and Collaborators
Taipei City Hospital
Chinese Medical Association
Investigators
Study Chair: Jung-Nien Lai, PHD Taipei City Hospital
  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 August 28, 2014