A Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Efficacy and Safety of Kami Guibi-tang (KGT) in Elderly Subjects with Insomnia
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0008391
- Lead Sponsor
- Kyung Hee University Oriental Medicine Hospital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 34
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index-Korean (PSQI-K)
- Secondary Outcome Measures
Name Time Method 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)