This study is a single-group (open-label) study to investigate the effects of CheonWangBoSim-dan on heart deficiency type insomnia and cardiac function and to predict drug response according to tongue diagnosis and oral microbiota. 
After 60 patients with insomnia were treated with 1 sachet (20 hwan) for 6 weeks once a day, we compared subjects' sleep state, autonomic nerve function, and cardiac function according to whether they had heart deficiency. Also we analyzed the biomarkers that can predict the efficacy of CheonWangBoSim-dan through the analysis of tongue coating and morphology, oral microbiota and serum metabolites analysis.

Treatment

Patients with insomnia should take 1 sachet (20 hwan) for 6 weeks once a day.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Patients with insomnia should take 1 sachet (20 hwan) for 6 weeks once a day.

Gender

Age

Description

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

Sleep duration on actigraph

Second visit, Week 6

Pittsburgh Sleep Quality Index (PSQI)

First visit, Week 3, Week 6, Week 10

Insomnia Severity Index (ISI)

First visit, Week 3, Week 6, Week 10

Beck Depression Index (BDI)

First visit

Cardiac function and Autonomic nervous function

Second visit, Week 3, Week 6

Aerobic Function

Second visit, Week 6

Vital signs

First visit, Second visit, Week 3, Week 6

Tongue morphology, Tongue Coating

Second visit, Week 6

Patterns of oral microbial flora and Genus or Species of each microbiota

Second visit, Week 6

Patterns of serum metabolome and Each metabolite

Second visit, Week 6