None listed
Conditions
Interventions
Drug : The suitable participants for this study are given a PLC or placebo ten times (5 times/2 weeks) or daily care management.
? PLC group: PLC (placenta pharmacopuncture 1.6 ml/subcutaneous injecti
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 19 years - 80 years 2. Total score in the Insomnia Severity Index (ISI)=15 points 3. Fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) diagnostic criteria for insomnia disorder 4. Willingness to participate in the trial and having provided written consent
Exclusion criteria
Exclusion criteria: 1. Having taken medicines improving insomnia within last 4 weeks for improving insomnia 2. Having undergone Korean medical treatment (eg, acupuncture, moxibustion, cupping, herbal medicine) within last 4 weeks for improving insomnia 3. Initiation the dietary supplement regimen or non-pharmacological therapies (eg, cognitive behavioural therapy, meditation, etc) for improving insomnia within the last 4 weeks or plans for initiation during the trial. 4. The patients with unstable(not controlled) schizophrenia, mania, bipolar disorder within last 6 months, or a subscale of either anxiety or depression in Hamilton Anxiety and Depression Scale score =11 points 5. Working shifts or changes in day/night work schedule that could impact circadian rhythm 6. Suffering from pain severe enough to cause sleep disturbance or presence of any disease that could cause insomnia 7. Abnormal findings in thyroid function test (abnormal level of free thyroxine (free T4) and thyroid-stimulating hormone (TSH) 5.1 µIU/mL) 8. Inadequate findings in laboratory test(total bilirubin> 2 times compared to the normal upper limit in research institute, ALT(Alanine transaminase) or AST(Aspartate transaminase) > 2.5 times compared to the normal upper limit in research institute, Creatinine > 2.5 times compared to the normal upper limit in research institute, positive in urine HCG, or other abnormal findings that could impact the trial by investigator’s decision) 9. Participants with electrolyte abnormality (K test values outside the normal range) 10. Diagnosed serious chronic disease (e.g. malignant tumor, active pulmonary tuberculosis, chronic liver disease or chronic kidney disease, other Rare Metabolic Diseases, Genetic Diseases, and Hormone Disorders ect.) 11. Participants with uncontrolled hypertension (hypertension with a systolic blood pressure exceeding 160 mgHg and diastolic blood pressure exceeding 95 mmHg) 12. Participants with a diabetes or insulin-dependent diabetes who is not controlled by hypoglicemic agents (HbA1c > 6.5 and above)hypoglycemic agent 13. Taking haemostatic agents (eg, Greenmono, Advate, Monoclate-P, Facnyne, BeneFix) because of cardiovascular or haemostatic disorders 14. Participants who is hypersensitive to PLC and other drugs. 15. Participants suspected of having a organic disorder. 16. Participants with psychogenic conditions 17. Pregnancy, lactation or planning to become pregnant 18. Having participated in other clinical trials within 12 weeks of the beginning of the trial 19. Difficulty complying with the study protocol(treatment, visiting, filling in questionnaries) 20. Subjects who are not appropriate by investigator’s decision
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index, PSQI ;Insomnia Severity Index (ISI) ;Pattern Identifications for Insomnia ;K-SCL95(Korean-Symptom Check List 95);Physical symptoms accompanied with insomnia ;EQ-5D(EuroQol-5 Dimension), EQ-VAS(EuroQol Visual analogue scale) SF-36(36-Item Short Form Survey);Hospital Anxiety and Depression Scale, Korean ver. HADS ;Sleep Diary ;actigraphy ;laboratory test ;Adverse effects ;blinding test | — |
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI) | — |
Countries
Korea, Republic of
Contacts
Public ContactJunghwa Lim
Pusan National University
Outcome results
None listed