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

Phase 2

Completed

• Conditions: Insomnia
• Interventions: Drug: TIAN WANG BU XIN DAN; Drug: Suan Tzao Ren Tang; Drug: Placebo

• Registration Number: NCT02319993
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2014-12-14
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-19
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-18
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Insomnia disorders in patients 20-80 years of age, the Pittsburgh Sleep Assessment Scale (PSQI)> 6 points.
• No insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction, heart rate is not the whole), hypertension, diabetes, cancer and so on.
• There are more than a week (including) three times to be more than 30 minutes to fall asleep and sleep less than six hours, there is a continuous months.
• Test subjects had to really understand the nature of this study, and participants signed consent.

Exclusion Criteria

• Before participating in this study, three months, had a major accident or wheel graveyard shift or jet lag problems (such as a long flight).
• Any insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction), poorly controlled hypertension (> 140 / 90mmHg), poorly controlled diabetes (HbA1C> 7%), cancer, digestive ulcers (undergoing treatment).
• 2 weeks into the experiment of taking melatonin or melatonin agonist, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, prostaglandins and other drugs.
• If patients sleep disorders arise from nighttime urinary frequency. Pregnant or breastfeeding person.
• Patients unable to read and fill out the questionnaire by themselves this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIAN WANG BU XIN DAN	TIAN WANG BU XIN DAN	Drug:TIAN WANG BU XIN DAN CONCENRATED GRANULES "CHUANG SONG ZONG"
Suan Tzao Ren Tang	Suan Tzao Ren Tang	Drug:Suan Tzao Ren Tang Granula Subtilae "CHUANG SONG ZONG"
Placebo	Placebo	Drug:1/10 TIAN WANG BU XIN DAN

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	4 weeks

Secondary Outcome Measures

Name	Time	Method
World Health Organization Quality of Life questionnaire	4 weeks