None listed
Conditions
Interventions
Drug : Oral administraion of Galgeun-tang-ga-cheongung-sinyi or placebo for up to 7 days, 3 times a day before or between meals
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged between 19 and 75 years 2. Those who are diagnosed with the common cold and the symptoms occur within 72 hours before starting the trial. 3. Those who have more than two symptoms related to the common cold including runny nose, nasal congestion, sneezing, sore throat, cough, headache, chills, and body aches. 4. Those whose nasal congestion severity score is more than 2 score. 5. Those who voluntarily decide to participate in this clinical trial and give written informed consent to abide by the precautions after hearing detailed explanation of this clinical trial and fully understanding it.
Exclusion criteria
Exclusion criteria: 1. Those with sinusitis, allergic rhinitis, pneumonia, influenza, COVID-19, cough or sore throat with sudden fever above 38 ?, bronchitis, otitis media, tonsillitis (if accurate examination is needed, paranasal sinuses (PNS) view or chest X-ray will be conducted). 2. Those diagnosed with chronic respiratory disease (chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, interstitial lung disease, and other chronic respiratory diseases). 3. Those who have taken antibiotics, antivirals, steroids, nasal decongestants, antihistamines, antitussives, expectorants, or other medications expected to alleviate symptoms of common cold within 1 week of screening. 4. Those with liver or renal impairment (alanine aminotransferase, aspartate aminotransferase, and creatinine = 3 times the upper normal limit at screening) 5. Those with generic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 6. Those with myopathy induced by pseudoaldosteronism or hypokalemia. 7. Those with comorbidities that interrupt the treatment of cancers or clinically significant disorders of the kidney, liver, psychiatric system, cardiovascular system, respiratory system, endocrine system, and central nervous system, which interrupt assessments of efficacy and safety or completion of the clinical study. 8. Those with unregulated hypertension (systolic blood pressure 160 mmHg = or diastolic blood pressure 100 mmHg =). 9. Those with unregulated diabetes mellitus (fasting blood sugar = 180 mg/dL). 10. Those with history of hypersensitivity reaction to materials of drugs used in this clinical trial. 11. Those with a history of alcoholism or substance abuse. 12. Current smokers or those with history of smoking more than 30 pack-year. 13. Pregnant or lactating women. 14. Those who do not use medically acceptable contraception (e.g., intrauterine device with proven pregnancy failure rate in spouse or partner, simultaneous use of barrier method for men or women with spermicide, or surgical procedures, such as vasectomy, tubectomy, tubal ligation, or hysterectomy for oneself or one’s partner) during the period from obtaining consent to completion of participation in this trial. 15. Those who participated in other clinical trials within 30 days before participation in this clinical trial. 16. Those determined by investigators to be ineligible to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total score (symptom score + quality of life score) of Wisconsin Upper Respiratory Symptom Survey-21-Korean version (WURSS-21-K) between baseline and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total score (symptom score + quality of life score) of WURSS-21-K between baseline time points (except for Day 7);Change in symptom score of WURSS-21-K between baseline time points;Change in quality of life score of WURSS-21-K between baseline time points;Change in Nasal Congestion Severity Score between baseline and time points;Change in Nasal Symptom Score VAS between baseline and time points;Change in Systemic Symptom Score VAS between baseline and time points;Duration of common cold symptom;Recovery of common cold;Global Evaluation of Efficacy Score;Chang in 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L) score between baseline and Day 7 | — |
Countries
Korea, Republic of
Contacts
Public ContactYee Ran Lyu
Korea Institute of Oriental Medicine
Outcome results
None listed