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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chung Shan Medical University

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.