Effect of CheonWangBoSim-dan on heart deficiency type insomnia and cardiac function and Prediction of drug response according to tongue diagnosis and oral microbiota

Dongguk University Ilsan Oriental Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新: 2019年4月23日

适应症

试验速览

暂无简介。

•1) Men and women aged 19 ~ 65
•2) Those who have experienced insomnia more than once a week in the past 3 months
•3) Those who have been diagnosed with primary sleep disorder
•4) Total score in the PSQI(Pittsburgh Sleep Quality Index)=6 points and total score in the Insomnia Severity Index (ISI)=8 points at the time of screening
•5) Total score in the BDI (Beck Compression Index)<24 points
•6) Those who understand this clinical trial, are willing to comply with the clinical protocol and to participate in it voluntarily

•1) Those who have suffered acute insomnia within the last 2 weeks
•2) History of heart disease (cardiac failure, angina pectoris, myocardial infarction, ischemic cardiac arrest)
•3) History of inducing insomnia (organic brain disorder such as stroke, encephalitis, etc., hypothyroidism, hypoglycemia, disorders of liver or kidney, chronic respiratory disease, etc)
•4) History of schizophrenia, bipolar disorder, severe depression or other mental disorders in the past or present
•5) Diseases that can affect sleep (pain, etc)
•6) Those who have adjusted insomnia-related drugs within a month
•7) Disagreement with the suspension of caffeine after 2 p.m.
•8) Disagreement with the principle of allowing only a drink after 6 p.m.
•9) Those who cannot use or is not eligible for an actigraph
•10) Taking beneficial bacteria supplementations or antibiotics in the last month
•11) Participation in other clinical trials within a month
•12) Subjects with prosthetic treatment
•13) Those who is judged to be unable to comply with the study decided by subinvestigator
•14) Those who have other conditions that can cause insomnia such as night shift workers
•15) Women who are pregnant or breastfeeding
•16) Other inappropriate reasons for study participation decided by principle investigator

发起方

Dongguk University Ilsan Oriental Hospital