Pharmacopuncture Effects on Insomnia Disorder

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 138

Inclusion Criteria

1) Adult men and women aged 19 to 80 years old.
2) Those with 15 or more Insomniia Severity Index (ISI) scores.
3) Those who meet the criteria for diagnosing insomnia in DSM-5
4) A person who agreed to participate and signed the subject's consent form after hearing a clear explanation of the purpose and characteristics of this clinical trial.

Exclusion Criteria

1) A person who has changed the type or dose of sleeping pills regularly taken to improve insomnia within the last 4 weeks.
2) A person who has received oriental medicine treatment (puncture, moxibustion, cupping, and herbal medicine) for the purpose of improving insomnia within the last 4 weeks.
3) A person who has started health supplements or other non-drug therapy (cognitive behavior therapy, meditation, etc.) for the purpose of improving insomnia within the last 4 weeks or is scheduled to start anew during clinical trials.
4) Those who have participated in other clinical trials with intervention within the last 4 weeks.
5) A person who changes shift work and working hours during the day and night that can clearly affect the living cycle.
6) A person with a clear pain enough to interfere with sleep or a disease that can cause sleep.
7) Those who have been diagnosed with unstable (controllable) schizophrenia, bipolar disorder, and other mental disorders in the last 6 months and are currently being treated, or those with an anxiety or depression score of 11 or higher on the Hospital Anxiety and Depression Scale (HADS)
8) A person diagnosed with a serious chronic disease or terminal disease (malignant tumor, tuberculosis, chronic liver disease, interstitial pneumonia, chronic renal disease, chronic heart disease, and other rare metabolic diseases, etc.) and is being treated.
9) Those with abnormal hormone levels on thyroid function tests (free T4 is abnormal and TSH <0.1 uIU/ml or TSH> 5.1 uIU/ml factor)
10) Those with clinically significant abnormalities in Blood chemistry (SGPT, SGOT: More than twice the upper limit of one or more of the two, serum creatinine: 1.5 times or more of the normal upper limit)
11) Those with electrolyte abnormalities (normal range of 5% or more and less).
12)High blood pressure patients who are not controlled by hypotension drugs (high blood pressure patients with systolic blood pressure exceeding 160mmHg and diastolic blood pressure exceeding 90mmHg)
13) Diabetes or insulin-dependent diabetes patients who are not controlled by blood glucose lowering agents (those with HbA1c greater than 7%)
14) Those who are taking blood coagulants (Greenmono, Advate, Monoclate-P, Facnyne, BenFix, etc.) due to cardiovascular abnormalities or hemostatic disorders.
15) A person who disagrees with the contraception method (double contraception method*, intrauterine contraceptive devices, and lethal drugs) recognized during the clinical trial period, with the possibility of pregnancy, lactating, and pregnant women.
16) In a case where it is deemed difficult to comply with the treatment, visit the hospital, or fill out a questionnaire under this protocol, etc.
17) In the case where the person in charge of other clinical research determines that it is inappropriate.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in the amount of change in the PSQI score.

Secondary Outcome Measures

Name	Time	Method
The difference in the amount of change in the ISI score.;The difference in the amount of change in the PSQI, ISI score.;The difference in the amount of change in the CSEI-S, Insomnia dialectic questionnaire.;The difference in the amount of change in the QOL(EQ-5D-5L, EQ-VAS, SF-36, HINT-8), consumption data analysis;Analysis of sleep quality and amount according to polysomnography.(Some of them are registered at Pusan National University Hospital);Analysis of Saliva(melatonine, cortisol)(Some of them are registered at Pusan National University Hospital)