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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003668

Enrollment

Registered

2019-03-26

Start date

2018-05-30

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Sleep duration on actigraph	—

Secondary

Measure	Time frame
Pittsburgh Sleep Quality Index (PSQI);Insomnia Severity Index (ISI);Beck Depression Index (BDI);Cardiac function and Autonomic nervous function;Aerobic Function;Vital signs;Tongue morphology, Tongue Coating;Patterns of oral microbial flora and Genus or Species of each microbiota;Patterns of serum metabolome and Each metabolite	—

Countries

Korea, Republic of

Contacts

Public ContactHojun Kim

Dongguk University

Outcome results