Ignite Creation Date:
2024-05-06 @ 3:32 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02319993
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2014-12-14
Brief Title:
Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia
Sponsor:
Chung Shan Medical University
Organization:
Chung Shan Medical University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None