Cold
Conditions
Interventions
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged from 18 to 65 years old (including 18 and 65 years old), regardless of ethnicity and gender; (2) clinically diagnosed as having a cold with two or more symptoms of rhinorrhea, nasal congestion, itchy nose and sneezing within 48 hours of onset of illness, which must include runny nose symptoms, and a runny nose symptom score of = 5.0 during the screening period; (3) able to understand the methodology of this study, willing to cooperate with the researchers, able to understand and accurately record the patient's diary card, and able to complete the follow up visits and examination items stipulated in the study protocol. (4) Have voluntarily signed the informed consent; (5) Not participating in any other drug clinical trials within 3 months prior to screening.
Exclusion criteria
Exclusion criteria: (1) Hypersensitivity to any component of this drug; (2) Acute rhinitis not due to cold, such as bacterial rhinitis (fever with pus and increased white blood cell count), allergic rhinitis (history of allergic rhinitis); (3) Comorbidities of glaucoma, cataracts, prostatitis and/or prostatic hypertrophy, and history of bladder neck obstruction; (4) Comorbidities of other nasal conditions that may cause intranasal drug deposition on physical examination, such as sinusitis, nasal polyps, or structural abnormalities of the nasal cavity; (5) History of nasal or ocular injury or surgery within three months prior to screening; (6) Other significant bronchial and pulmonary disease, including: asthma, pneumonia; (7) Those with significant diseases such as myotonic dystrophy, congenital immunodeficiencies, malignant tumors, autoimmune diseases, and airway developmental abnormalities; (8) History of severe cardiovascular system diseases: e.g., uncontrolled hypertension, acute myocardial infarction, unstable angina pectoris, chronic cardiac insufficiency, life-threatening cardiac arrhythmias such as ventricular tachycardia or ventricular fibrillation; (9) Laboratory test results show that ALT is more than 2 times the upper limit of normal values specified by the Center, or serum creatinine is more than 1.2 times the upper limit of normal values specified by the Center; (10) Laboratory test results show that the total number of white blood cells (WBC) is more than the upper limit of normal value specified by the Center or the neutrophil (N) classification is >80%; (11) Discontinuation of the following medications for less than 24 hours prior to the first dose: - Systemic or topical corticosteroids - Corticosteroids, systemic or topical Loratadine and Desloratadine - Loratadine and diclofenac Loratadine and diclofenac Other H1-antihistamines - Leukotriene antagonists and synthesis inhibitors - Any decongestant - Ketotifenol - Tricyclic antidepressants - All types of herbal preparations for rhinitis (12) Alcohol abuse (males: more than 4 units per day or 14 units per week; females: more than 3 units per day or 7 units per week; 1 unit = 355 ml of beer or 150 ml of wine or 35 ml of wine (52°)), drug use, or substance abuse, as judged by the investigator, that interferes with the conduct of the study; (13) Pregnant or lactating women, or patients who do not wish to use effective birth control during the study. Reliable birth control measures include transdermal patches, intrauterine devices/systems (IUD/IUS), oral, implanted, or injectable contraceptives, abstinence and spousal vasectomy, and condom use; (14) Persons who are mentally incompetent or unable to properly cooperate in the conduct of the study; (15) Other reasons that the investigator considers inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analog scale;Area under the runny nose symptom severity score-time curve.; | — |
Countries
China
Contacts
Public ContactLiu Chuntao
West China Hospital, Sichuan University
Outcome results
None listed