Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The investigators intend to conduct a multicenter clinical trial to verify the effectiveness and safety of the administration of 'Eungyosan(EGS)' and 'Samsoeum(SSE)' in cold patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korean Medicine Hospital of Pusan National University

Criteria

Inclusion Criteria:

1. Male and female aged between 19 and 60 years as of the screening date

2. Onset of cold symptoms within 48 hours before screening

3. Those who have one or more of the symptoms and related symptoms of runny nose and sore throat (Related symptoms: nasal congestion, sneezing, sore throat, cough, sore throat, headache, chest tightness, fatigue)

4. Those who demonstrate understanding of the study details and have willingness to participate as evidenced by voluntary written informed consent

5. Those who can be followed up during the clinical trial

6. Those who do not meet the exclusion criteria

Exclusion Criteria:

1. Those who have sinusitis (when the sinus is opaque at the time of examination through the transillumination of the maxillary sinus and the frontal sinus), allergic rhinitis, pneumonia, flu (when coughing or sore throat with sudden fever above 38 ℃), bronchitis, otitis media, tonsillitis (PNS view, Chest Xray test if accurate test is needed)

2. Those who have chronic respiratory disease (chronic obstructive pulmonary disease, interstitial lung disease) and asthma

3. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, or other medications that are expected to alleviate cold symptoms, or those who have taken food that is expected to relieve cold symptoms within one week of the start of the study

4. Those who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure, etc.

5. Those who have systemic disease or autoimmune disease which does not affect cold symptoms

6. Those who have severe mental illnesses such as depression or anxiety disorders, or those who are currently taking psychoneurological drugs such as antidepressants

7. Drug addicts or alcoholics

8. Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 3 times the upper limit of normal

9. Creatinine exceeds twice the upper limit of normal of the research institute

10. Weak person (less than body weight index (BMI) 18.5, clinically judged by Korean medical doctor through physical examination)

11. Those who have a weak stomach and are considered to be inadequate to take investigational drug (clinically judged by Korean medical doctor through physical examination)

12. Those who are with high blood pressure (vital sign measured at upper left after resting for at least 5 minutes at screening: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg) or elderly

13. Those who have cardiac disorder or renal disorder (clinically judged by Korean medical doctor through physical examination, ECG, and serum biochemistry)

14. Those who have histories of hives, rash, or itching while taking medicines

15. Participants in other clinical trials within one month of the start of the trial (30 days prior to the screening visit) or plan to participate in other clinical trials during the trial

16. Pregnant women or women who may be pregnant

17. Those who do not agree to contraception in case of women of childbearing age

18. Those who are being held in group facilities such as social welfare facilities

19. Those who are inappropriate to participate in the trial by the investigator's judgment

20. Those who have hypersensitivity to the investigational drug (main ingredient and its components)

21. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

22. Those who have hypokalemia

23. Those who have difficulty in daily life due to sweats (excessive sweating, general weakness, etc.)

24. Those who have difficulty in daily life due to anorexia, nausea or vomiting

25. Those who are suspected of having pneumonia and need antibiotic treatment or those who are receiving medical treatment (those receiving other medications)