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Eunkyosan and Samsoeum for Common Cold

Efficacy, safety and economic evaluation of Eun-kyo-san and Sam-so-eum on common cold: randomized, placebo controlled, multicenter trail

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006307
Enrollment
375
Registered
2021-06-30
Start date
2019-10-11
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Medicines used in clinical trials are packaged and supplied with 24 daily doses (Eungyosan: 1 daily intake
3 daily intake
2.3g 1 daily
Samsoeum:3 daily intake
3 times, 3.37g 1 daily intake
Control: 1 daily intake
3 times, 3.0g 1 package each).

Sponsors

Pusan National University Korean Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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)

Design outcomes

Secondary

MeasureTime frame
Total scores of WURSS-21-K;Quality of life score of WURSS-21-K;Symptom duration;VAS scale

Primary

MeasureTime frame
WURSS-21-K total scores;ICER, ICUR

Countries

Korea, Republic of

Contacts

Public ContactJun-Yong Choi

Pusan National University Korean Medicine Hospital

orientdoct@gmail.com+82-55-360-5953

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026