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

NCT01267539 | Completed DMC

• 1 other identifier: TCHIRB-970110-E
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopausal and Female Climacteric States

Keywords

Suan Zao Ren Tang, climacteric, PSQI, WHOQOL-BREF

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei City Hospital: lead
• Chinese Medical Association: collaborator

Study Sites (1)

Taipei City Hospital

Taipei, Taiwan, 111, Taiwan

Location

Study Officials

• Jung-Nien Lai, PHD

  Taipei City Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 28, 2010
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 28, 2010

Record last verified: 2008-01

Locations

TW (1)