KCT0005127
Completed
未知
Hominis Placenta Pharmacopuncture for treating insomnia disorder: randomized placebo controlled, assessor single-blinded, pilot clinical trial study
Pusan National University Korean Medicine Hospital0 sites51 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pusan National University Korean Medicine Hospital
- Enrollment
- 51
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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) \<0\.1 µIU/mL or 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.)
Outcomes
Primary Outcomes
Not specified
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