None listed
Conditions
Interventions
Drug : 1. Experimental group
Kamiguibi-tang, 3 times a day for 12 weeks, oral intake
2. Control group
placebo, 3 times a day for 12 weeks, oral intake
Sponsors
Kyung Hee University Oriental Medicine Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 65 or older who complain of insomnia according to the criteria presented by DSM-5 2. Insomnia Severity Index - Korean (ISI-K) score of 8 or higher 3. SCD-Q score of 7 or more and a KDSQ-C score of less than 6 4. Those who have not received any new treatment related to insomnia within the last 2 weeks: Non-drug treatment and drug treatment 5. Those who have not received cognitive-related drug treatment within the last 2 weeks 6. Those who have been in a stable state for more than four weeks without any change in the medication taken for the underlying disease and is scheduled to be administered stably during the trial period 7. Those who have no communication problems 8. Those who voluntarily decide to participate and sign the consent form
Exclusion criteria
Exclusion criteria: 1. Diagnosed with dementia according to the NINCDS-ADRDA criteria 2. Diagnosed with mild cognitive impairment according to the diagnosis criteria of mild cognitive impairment suggested by Albert et al. 3. Brain diseases that cause other neurological symptoms 4. Those who have a mental disorder, have behavioral problems that require treatment with psychotropic drugs, or are taking psychotropic drugs 5. Substance abuse (drug addiction, alcoholism, etc.) 6. Life-threatening physical disabilities requiring immediate treatment 7. Uncontrolled hypertension 8. Heart or renal disease 9. Peripheral edema 10. Gastrointestinal symptoms, such as anorexia, stomach discomfort, nausea, abdominal pain, and diarrhea 11. Use of medications that could induce hypokalemia or myopathy 12. Hypersensitivity to the medication used in the study 13. Clinically significant abnormalities in blood chemistry, including levels of serum glutamic pyruvate transaminase (SGPT)/serum glutamic oxaloacetic transaminase (SGOT) being more than twice the normal upper limit, or serum creatinine levels more than 10% above the normal upper limit 14. Participation in any other clinical trial within the previous 4 weeks 15. Iliteracy 16. Considered unsuitable for participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index-Korean (PSQI-K) | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index-Korean (ISI-K);Seoul Neuropsychological Battery (SNSB-D);36-item MOS Short Form 36 (SF-36);Short form Geriatric Depression Scale-Korean (S-GDS) | — |
Countries
Korea, Republic of
Contacts
Public ContactKyeonghwa Lee
Kyung Hee University Oriental Medicine Hospital at Gangdong
Outcome results
None listed