Evaluate the Efficacy and Safety of Andrographolide Sulfonate in Patients With Acute Tonsillitis (NCT03134443) | Clinical Trial Compass
UnknownPhase 4
Evaluate the Efficacy and Safety of Andrographolide Sulfonate in Patients With Acute Tonsillitis
China144 participantsStarted 2016-12-01
Plain-language summary
A multicenter, randomized, single-blind, placebo-controlled,phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute tonsillitis
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1.18-65 years, males or females;
* 2.patients met the acute tonsillitis diagnosis;
* 3.patients'all symptoms (including cough) appeared no longer than 72 h before inclusion to the trial
* 4.patients compliance is good, written informed consent was obtained from all participants before the study.
Exclusion Criteria:
* 1.Patients had a history of andrographolide sulfonate or andrographolide allergy.
* 2.Pregnancy, lactation, and absence of contraception in women of fertile age.
* 3.Judging by the researchers, Past or present illness of patients may affect to participate in the trial or affect the outcome of the study, including cardio-pulmonary diseases, malignant diseases, autoimmune diseases, hepatorenal disease, blood diseases, nervous system diseases, immune system diseases and endocrine diseases.
* 4.After checking, Patients with pulmonary tuberculosis, bronchial asthma, bronchial pneumonia, bronchiectasis, pneumoconiosis, silicosis, lung cancer, pulmonary infiltration or other allergic respiratory diseases and other chronic lung diseases
* 5.Patients using systemic steroids or other immunosuppressive therapy
* 6.Patients with severe cardiopulmonary dysfunction, abnormal liver and kidney function, blood system diseases.
* 7.Patients are alcohol (daily drink alcoholic wine is more than 40g) or drug abuse or drug addicts in the past year.
* 8.Patients were participated in any study of drug trials in the last 30 days.
* 9.According to the researchers'…