Safety and efficacy of Eucalyptol, Limonene and Pinene Enteric Soft Capsules in chronic sinusitis: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase IV clinical trials
- Conditions
- chronic sinusitis
- Registration Number
- ITMCTR2100004260
- Lead Sponsor
- EYE & ENT Hospital of Fudan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Patients who meet all of the following criteria can be included in this study:
(1) At the time of informed consent, the age is 18-60 (including the critical value), and the gender is not limited;
(2) According to the diagnostic criteria of the Guidelines for the Diagnosis and Treatment of Chronic Sinusitis in China (2018 Edition), diagnosed as chronic sinusitis without nasal polyps and with symptoms more than 12 weeks;
(3) Glucocorticoids (oral or nasal spray) have not been used within 2 days before the first administration, including: mometasone furoate, budesonide, prednisone, prednisolone, betamethasone and hydrocortisone Wait. Have not used clarithromycin in the treatment of chronic sinusitis within 2 days; have not used azithromycin in the treatment of chronic sinusitis within 10 days; have not used cephalosporin (cefaclor, cefprozil or cefuroxime axetil) or amoxicillin in the treatment of chronic sinuses within 1 day Inflammation; have not used third-generation antihistamines (including fexofenadine, levocetirizine) within 3 days; have not used second-generation antihistamines (including terfenadine, a Semizole, etc.); have not used the first-generation antihistamines (including diphenhydramine, etc.) within 1 day; have not used leukotriene receptor antagonists (including: montelukast, zarus) within 3 days Special Class) Treatment of chronic sinusitis.
(4) Good health: medical history of heartlessness, liver, kidney, digestive tract, nervous system, mental abnormalities and metabolic abnormalities; physical examination, vital signs measurement, clinical laboratory examination (blood routine, urine routine, blood biochemistry, blood coagulation function ), those with normal or abnormal ECG results without clinical significance;
(5) MSS score >= 6 points
(6) Subjects (including male subjects) have no pregnancy plan within 1 day from the screening visit to the end of the treatment period and voluntarily take effective contraceptive measures;
(7) Subjects can understand the purpose and risks of the research, are willing to participate in the research and sign written informed consent.
Patients who meet any of the following conditions will not be able to participate in this study:
(1) Those who may be allergic to budesonide nasal spray, this product, or both of its accessories, as judged by the researcher;
(2) Those with unilateral or bilateral nasal polyps, or those with a history of unilateral or bilateral nasal polyps;
(3) Patients with the following conditions: ocular complications (periorbital cellulitis, orbital subperiosteal abscess, intraorbital cellulitis, intraorbital abscess, retrobulbar optic neuritis, etc.), intracranial complications (epidural abscess , Subdural abscess, purulent meningitis, brain abscess and cavernous sinus thrombophlebitis, etc.), adenoid hyperplasia, tonsil hypertrophy, airway hyperresponsiveness, posterior nostril polyps, nasal inverted papilloma, nasopharyngeal Fibrovascular tumors, malignant tumors of the nasal cavity and paranasal sinuses, vasculitis, cystic fibrosis, and primary ciliary dyskinesia;
(4) Patients with fungal sinusitis, allergic rhinitis or drug-induced rhinitis;
(5) Subjects with refractory sinusitis;
(6) Acute upper respiratory tract infection occurred within 2 weeks before screening;
(7) There is an anatomical abnormality in the nasal septum that seriously affects the ventilation of the sinuses and paranasal sinuses;
(8) Those who have received nasal external ear surgery within 3 months before screening;
(9) Those suffering from digestive system diseases (such as peptic ulcer) that may affect the oral absorption of the drug;
(10) Those who are accompanied by respiratory diseases [asthma (including allergic asthma), chronic obstructive pulmonary disease (COPD), emphysema, bronchitis, etc.] who have been judged by the investigator to influence the evaluation of the test;
(11) People with a history of aspirin aggravating respiratory diseases;
(12) Those who have a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance;
(13) Pregnant or lactating women;
(14) Those who have participated in other clinical trials within 3 months before screening, or are participating in other clinical trials;
(15) The investigator believes that any other situations that are not suitable for participating in this study, or the subjects' participation in the test may affect the test results or their own safety.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major Symptom Score by investigator;
- Secondary Outcome Measures
Name Time Method und-Kennedy;Visual analogue scale;Major Symptom Score by investigator;SNOT-22;CT Lund-Mackay;Major Symptom Score by patient;Disease control rate;