None listed
Conditions
Interventions
Drug : Oral administration of two tablets of GHX02 and one tablet of Umckamin placebo in the GHX02 group, or two tablets of GHX02 placebo and one tablet of Umckamin in active control group for 7 days,
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 19-65 years 2. Patients with acute bronchitis whose BSS >5 points at visit 2 (Day 1) within 14 days of onset 3. Patients who voluntarily agreed to participate in this clinical trial in written form
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Patients who take other investigational products, adrenocorticoids or immunosuppressants, antibiotics, bronchodilators within 4 weeks before participation in the clinical trial; 3. Patients who take antihistamines, antitussives, and expectorants within 7 days before participation in the clinical trial; 4. Patients who have been taking or have taken angiotensin-converting-enzyme inhibitors within 4 months 5. Patients who need treatment of bronchodilators, steroids, and antibiotics; 6. Patients with severe respiratory diseases that affect evaluation of the efficacy of investigational products (pneumonia, bronchiectasis, active tuberculosis, COPD classified as GOLD Stage I and mild (FEV1/FVC ) or more severe COPD, and lung cancer) 7. Patients with suspicious findings of pneumonia in chest X-ray, blood test, auscultation, and vital sign 8. Patients with liver or renal impairment (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and creatinine > 2 times the upper normal limit at screening) 9. Patients with generic disorders, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 10. Patients with clinically significant diseases or disorders in liver, kidney, cardiovascular system, respiratory system, endocrine system, and central nervous system in physical examination and clinical test, or with history of psychiatric disorder or malignant tumor (participation is possible if malignant tumor dose not recur for more than 5 years after surgery) 11. Patients with history of hypersensitivity reaction to materials of drugs used in this clinical trial 12. Patients with history of alcoholism or substance abuse 13. Patients with history of smoking more than 30 pack-year 14. Patients 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. Patients who participated in other clinical trials administering investigational products within 30 days before participation in this clinical trial 16. Patients determined by investigators to be ineligible to participate in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Bronchitis Severity Score (BSS) score between baseline and Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Questionnaire on Clinical Symptoms of Cough & Sputum (QCSCS) between baseline and Visit 3;Change in Leicester Cough Questionnaire-acute (LCQ-acute) between baseline and Visit 3;Change in frequency of coughing fits between baseline and time points (Day1-Day7);Integrative Medicine Outcome Scale (IMOS) score at Visit 3;Integrative Medicine Patient Satisfaction Scale (IMPSS) score at Visit 3 | — |
Countries
Korea, Republic of
Contacts
Public ContactYang Chun Park
Daejeon Korean Medicine Hospital of Daejeon University
Outcome results
None listed