None listed
Conditions
Interventions
Drug : Intervention: Galgeun-tang-ga-cheongung-sinyi (solid extract 1.4g per pack)[Kakkontokasenkyushin’i in Japanese, Gegen-tang-jia-chuanxiong-xinyi in Chinese], 3 times a day for 8 weeks, oral admi
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women aged 19 to 60 years at the screening visit 2. A diagnosis of CRS based on the presence of rhinosinusitis symptoms for more than 12 weeks A. Presence of more than two major symptoms or one major symptoms and two minor symptoms i. Major symptoms: facial pain/pressure, nasal obstruction/blockage, nasal discharge/purulence/discoloured post-nasal drainage, hyposmia/anosmia, purulence observed in the nasal cavity on examination ii. Minor symptoms: headache, fever, halitosis, fatigue, dental pain, cough, ear pain/pressure/fullness B. A diagnosis of rhinosinusitis based on paranasal sinus computed tomography (CT) findings 3. A Sino-Nasal Outcome Test-22 (SNOT-22) score of =20 at the screening visit 4. Ability to comprehend the purpose and process of the study as well as the properties of the investigational drug and voluntary provision of written informed consent
Exclusion criteria
Exclusion criteria: 1. A previous history of nose-related or allergy-related diseases and treatment A. Nasal polyps, cystic fibrosis, primary ciliary dyskinesia, untreated deviated nasal septum B. Acute bacterial exacerbation of CRS (acute pain, acute pressure, fever, pus on discharge) C. Acute complication of CRS (abscess) D. Orbital or central nervous system complications of CRS E. Acute respiratory infection developed within the last 7 days F. Use of topical decongestants or cromolyn sodium within the last 3 days G. Use of antibiotics, antihistaminics, anticholinergics, and intranasal steroids within the last 1 week H. Use of oral steroids or leukotriene receptor antagonists within the last 4 weeks I. Receipt of immunotherapy within the last 5 years 2. Presence of serious medical conditions that could interfere with clinical trial participation A. Uncontrolled hypertension (systolic blood pressure = 160 mmHg and diastolic blood pressure = 100 mmHg) B. Uncontrolled diabetes mellitus (HbA1c = 6.5%) C. Abnormal kidney function test results showing blood creatinine levels that are more than twice the upper limit of the normal range D. Abnormal liver function test results showing alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels that are more than twice the upper limit of the normal range E. Serious hyperlipidaemia, anaemia, active tuberculosis, thyroid disease, and other serious inflammatory and systemic diseases F. Past or present history of malignant tumors 3. Pregnancy, planning a pregnancy, or breastfeeding 4. Hypersensitivity to the investigational drug or any of its components 5. Participation in other clinical trials within the past 1 month 6. Communication difficulties that will not allow proper compliance with the investigator’s instructions 7. Ineligibility for participation as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sino-Nasal Outcome Test-22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Lund-Mackay score;Total Nasal Symptom Score;EuroQoL 5 Dimensions 5 Levels;Nasal endoscopy index;Serum ImmunoglobulinE | — |
Countries
Korea, Republic of
Contacts
Public ContactDong-Hyo Lee
Woosuk University
Outcome results
None listed