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

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

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: TIAN WANG BU XIN DAN; Drug: Suan Tzao Ren Tang; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIAN WANG BU XIN DAN; Drug:TIAN WANG BU XIN DAN CONCENRATED GRANULES "CHUANG SONG ZONG"	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.; Other Names: TWBXD
Experimental: Suan Tzao Ren Tang; Drug:Suan Tzao Ren Tang Granula Subtilae "CHUANG SONG ZONG"	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.; Other Names: STRT
Placebo Comparator: Placebo; Drug:1/10 TIAN WANG BU XIN DAN	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.; Other Names: P

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pittsburgh Sleep Quality Index (PSQI)	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
World Health Organization Quality of Life questionnaire	4 weeks

Collaborators and Investigators

• Sponsor: Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 14, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 18, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Quality of life; Traditional Chinese Medicine; Suan-Zao-Ren Tang; Tian-wang-bu-xin-dan; Herbs
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: CSH-CMCTC-101-001