NCT02319993

Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia.

Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia. A Multi-center Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Chung Shan Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

keywords： Traditional Chinese Medicine, Herbs, Clinical trial, Insomnia, Quality of life, Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan

Detailed description

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	TIAN WANG BU XIN DAN	assigned to TWBXD (n =48) and were instructed to take 6 gm 2 times per day of TWBXD for a period of 4 weeks.
DRUG	Suan Tzao Ren Tang	assigned to SZRT (n = 48) and were instructed to take 6 gm 2 times per day of SZRT for a period of 4 weeks.
DRUG	Placebo	1/10 TIAN WANG BU XIN DAN assigned to placebo (n =32) and were instructed to take 6 gm 2 times per day of placebo for a period of 4 weeks.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-12-19
• Last updated: 2016-01-20