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

NCT02319993 | Completed Phase 2 DMC

• 1 other identifier: CSH-CMCTC-101-001
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Insomnia

Keywords

Suan-Zao-Ren Tang; Tian-wang-bu-xin-dan; Traditional Chinese Medicine; Herbs; Quality of life

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  4 weeks

Secondary Outcomes (1)

• World Health Organization Quality of Life questionnaire

  4 weeks

Study Arms (3)

TIAN WANG BU XIN DAN

EXPERIMENTAL

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

Drug: TIAN WANG BU XIN DAN

Suan Tzao Ren Tang

EXPERIMENTAL

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

Drug: Suan Tzao Ren Tang

Placebo

PLACEBO COMPARATOR

Drug:1/10 TIAN WANG BU XIN DAN

Drug: Placebo

Interventions

TIAN WANG BU XIN DAN 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.

Also known as: TWBXD

TIAN WANG BU XIN DAN

Suan Tzao Ren Tang 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.

Also known as: STRT

Suan Tzao Ren Tang

Placebo 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.

Also known as: P

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine

Study Record Dates

• First Submitted: December 14, 2014
• First Posted: December 19, 2014
• Study Start: May 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 20, 2016

Record last verified: 2016-01