Insomnia
Conditions
Keywords
Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan, Traditional Chinese Medicine, Herbs, Quality of life
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.
Interventions
DRUGTIAN 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.
DRUGSuan 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.
DRUGPlacebo
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.
Sponsors
Chung Shan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| World Health Organization Quality of Life questionnaire | 4 weeks |
Outcome results
None listed