Insomnia Clinical Trial
Official title:
Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia. A Multi-center Clinical Trial
keywords： Traditional Chinese Medicine, Herbs, Clinical trial, Insomnia, Quality of life, Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan
Title： Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in patients
with primary insomnia. A multi-center, double blind, placebo controlled clinical trial.
(First year of two-years' project)
Design:
Randomized, placebo-controlled trial comprising 3 arms: SZRT, placebo, TWBXD.
Setting:
The Chung Shan Medical University Affiliated Hospital and the Taipei City Hospital.
Methods:
A total of 128 subjects 20-80 years of age with a history of insomnia at least 1 month were
recruited randomly assigned to SZRT (n = 48), placebo (n =32), TWBXD (n =48) and were
instructed to take 6 gm 2 times per day of SZRT, TWBXD or placebo for a period of 4 weeks.
The primary outcome measures were the mean component scores of the Pittsburgh Sleep Quality
Index (PSQI). Secondary outcome parameter were the global score on the World Health
Organization Quality of Life questionnaire - Taiwan brief version, drugs consumption counts,
sleep diary and safety profiles by structures questionnaires.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment
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