GamiGuipi-Tang for Treating Insomnia Disorder : multi-site, randomized controlled double-blind, comparative clinical trial study
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0003811
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 96
1. Male and female candidates aged 19 or older and under 80 years old
2. Individuals with an Insomnii Severity Index (ISI) score of 15 or more.
3.Those who meet the DSM-5 criteria for diagnosing insomnia
4. Those who voluntarily agreed to participate after hearing a sufficient explanation of the purpose and implementation of this clinical trial
1. Those who vary in the type or capacity of sleeping pills they take regularly to improve their insomnia within the last four weeks.
2. Those who have received oriental medicine treatment (e.g., acupuncture, moxibustion and herbal medicine) for the purpose of improving insomnia within the last 4 weeks
3. Persons who have started health supplements, or other non-drug treatments (cognitive behavior therapy, meditation, etc.) for the purpose of improving their insomnia within the last four weeks or are planning to start anew during clinical trials
4. Those who have been diagnosed with major depression, anxiety disorder, panic disorder, and other mental disorders, or who have been diagnosed with caffeine, alcohol or drug addiction, or those with a anxiety or depression score of 11 or more points in HADS (Hospital Anxiety and Depression Scale).
5. Shift shifts that can clearly affect the life cycle, and shift hours during the day.
6. A person with a condition that can cause a clear pain or insomnia to disturb to sleep.
7. Abnormal hormone levels in thyroid functional assay ( TSH < 0.1 uIU/ml or TSH > 5.1 uIU/ml)
8. Patients with clinically significant anomalies in Blood chemistry (SGPT, SGOT: at least two times the upper limit, serum creatinine: 1.5 times the normal upper limit)
9. Persons with electrolyte anomalies (K test readings outside normal range)
10. Persons diagnosed with severe chronic or terminal diseases (such as malignant tumors, tuberculosis, chronic liver disease, epileptic pneumonia, chronic new disease, chronic heart disease, and other rare metabolic disorders)
11. Patients with unregulated hypertension (high blood pressure of 160 mgHg in the condenser and patients with high blood pressure exceeding 95 mmHg in the relaxation period)
12. Patients with diabetes or insulin-dependent diabetes who are not controlled by blood glucose reduction
13 A person who shows low potassium haemorrhosis or who is administering drugs (such as furosemide, thiazide, amphetamine,cisplatin,etc) and a condition that can show low potassium haemorrhosis (such as low magnesium haemorrhosis,Barter syndrome,githelman synthemia,etc) that can cause this.
14.A person who is taking blood clotting agents (Greenmono, Advocate, Monoclate-P, Facnye, BenFix, etc.) for cardiovascular disorders or haemostatic disorders
15. Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptive disorder.
16. Those who do not agree with the contraceptives (dual contraceptives*, intrauterine contraceptives, and murder agents) that are recognized during clinical trials.
17. Anyone who has participated in other clinical trials with interventions within the last four weeks
18. If compliance with this protocol is deemed difficult, such as treatment, referral, or preparation of questionnaire
19. Other clinical research personnel find it inappropriate
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in score changes before and after drug administration of Insomnia Severity Index (ISI)
- Secondary Outcome Measures
Name Time Method Differences in score changes before and after drug administration of PSQI;Stability assessment-Assessment of SAE, AE and AR through examination of the clinical laboratory by the physician in charge;Economical assessment items-SF36, EQ-5D, EQ-VAS, Cost assessment;Comparison of changes in K-SCL-95 before and after drug administration;D.I.T.I. assay--Comparison of temperature changes before and after drug administration in the face (e.g., forehead, cheeks), body (difference in temperature in the JunJung region, jungwan region, and Gwanwon-Gihae region)