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

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TIAN WANG BU XIN DAN
Suan Tzao Ren Tang
Placebo
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan, Traditional Chinese Medicine, Herbs, Quality of life

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    TIAN WANG BU XIN DAN

    Suan Tzao Ren Tang

    Placebo

    Arm Description

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

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

    Drug:1/10 TIAN WANG BU XIN DAN

    Outcomes

    Primary Outcome Measures

    Pittsburgh Sleep Quality Index (PSQI)

    Secondary Outcome Measures

    World Health Organization Quality of Life questionnaire

    Full Information

    First Posted
    December 14, 2014
    Last Updated
    January 18, 2016
    Sponsor
    Chung Shan Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02319993
    Brief Title
    Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia.
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chung Shan Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia
    Keywords
    Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan, Traditional Chinese Medicine, Herbs, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    128 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TIAN WANG BU XIN DAN
    Arm Type
    Experimental
    Arm Description
    Drug:TIAN WANG BU XIN DAN CONCENRATED GRANULES "CHUANG SONG ZONG"
    Arm Title
    Suan Tzao Ren Tang
    Arm Type
    Experimental
    Arm Description
    Drug:Suan Tzao Ren Tang Granula Subtilae "CHUANG SONG ZONG"
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Drug:1/10 TIAN WANG BU XIN DAN
    Intervention Type
    Drug
    Intervention Name(s)
    TIAN WANG BU XIN DAN
    Other Intervention Name(s)
    TWBXD
    Intervention Description
    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
    Intervention Name(s)
    Suan Tzao Ren Tang
    Other Intervention Name(s)
    STRT
    Intervention Description
    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
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    P
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pittsburgh Sleep Quality Index (PSQI)
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    World Health Organization Quality of Life questionnaire
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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