Eunkyosan and Samsoeum for Common Cold
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0006307
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 128
1. Men and women aged 19 to 60 as of the screening date
2. Who is diagnosed with a cold and whose symptoms are within 48 hours before clinical trial begins
3. Those who have one or more additional symptoms related to runny nose and sore throat (related symptoms: stuffy nose, sneezing, sore throat, coughing, hoarse throat, headache, stuffy chest, tiredness)
4. A person who has fully understood the detailed explanation of this clinical trial, decides to participate voluntarily, and agrees in writing to comply with the precautions
5. A person who can be monitored during the clinical trial period
6. Persons not included in the exclusion criteria
1. People suffering from sinusitis (transillumination of maxillary and frontal regions), allergic rhinitis, pneumonia, flu (cough or sore throat with sudden fever above 38°C), bronchitis, middle ear inflammation, and tonsillitis (pNS view if correct examination is required)
2. Chronic respiratory disease (chronic obstructive pulmonary disease, epileptic pulmonary disease) and asthma sufferers
3. If you have taken antibiotics, antivirals, steroids, non-infectious drugs, anti-histamines, or other medications that are expected to alleviate cold symptoms within one week of the test start date, or if you have taken them, or if you have taken food that is expected to alleviate cold symptoms.
4. A person who is being treated for liver cancer or cirrhosis, chronic kidney failure, congestive heart failure, etc.;
5. A person who has no effect on cold symptoms but has a systemic or autoimmune disease.
6. A person who has severe mental illness, such as depression or anxiety disorder, or is currently taking drugs for the mental nervous system, such as antidepressants;
7. Drugs or alcoholics
8. A person whose ALT (Alanine transaminase) or AST (Aspartate transaminase) exceeds three times the normal upper limit of the institution.
9. A person whose creatinine exceeds twice the normal upper limit of a research institute
10. A person with a weak body (below BMI 18.5, clinically judged by an oriental medical doctor through a scientific examination)
11. A person who is considered inappropriate to take clinical trial medications due to his/her weak stomach (clinically judged by an oriental medical doctor through a scientific examination)
12. Patients with high blood pressure (at screening, systolic blood pressure =160 mmHg or relaxation pressure = 100 mg) or elderly people at vital signs measured from the left or left after a rest of at least 5 minutes.
13. Patients with heart or kidney impairment (clinically determined by an oriental medical doctor through a scientific examination, electrocardiogram, and serum biochemical examination)
14. Patients who have experienced hives, redness, or itching while taking medication so far
15. A person who has participated in another clinical trial within one month prior to the commencement of this trial (30 days prior to the date of the screening visit) or plans to participate in another clinical trial during the trial period.
16. A woman who is pregnant or possibly pregnant
17. A woman of childbearing age who disagrees with contraception
18. Persons who are housed in collective facilities, such as social welfare facilities;
19. Any other person deemed inappropriate by the judgment of the tester;
20. Patients with genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption.
21. Persons with hypersensitivity to clinical trial medications (main ingredients and their components)
22. A person with hypokalemia
23. Patients who sweat so much that their daily lives are difficult (excessive sweating, general lethargy, etc.)
24. A person who has difficulty in daily life due to poor appetite, nausea, and vomiting;
25. A person who is suspected of pneumonia and is deemed to need antibiotic treatment or who is receiving medical treatment (someone who is receiving other medications)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method WURSS-21-K total scores;ICER, ICUR
- Secondary Outcome Measures
Name Time Method Total scores of WURSS-21-K;Quality of life score of WURSS-21-K;Symptom duration;VAS scale