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

NCT ID: NCT02319993

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-10-31

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TIAN WANG BU XIN DAN

Drug:TIAN WANG BU XIN DAN CONCENRATED GRANULES "CHUANG SONG ZONG"

Group Type: EXPERIMENTAL

TIAN WANG BU XIN DAN

Intervention Type: DRUG

assigned to TWBXD (n =48) and were instructed to take 6 gm 2 times per day of TWBXD for a period of 4 weeks.

Suan Tzao Ren Tang

Drug:Suan Tzao Ren Tang Granula Subtilae "CHUANG SONG ZONG"

Group Type: EXPERIMENTAL

Suan Tzao Ren Tang

Intervention Type: DRUG

assigned to SZRT (n = 48) and were instructed to take 6 gm 2 times per day of SZRT for a period of 4 weeks.

Placebo

Drug:1/10 TIAN WANG BU XIN DAN

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

TWBXD; STRT; P

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

GCRC

Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CSH-CMCTC-101-001

Identifier Type: -

Identifier Source: org_study_id