Acute Tonsillitis
Conditions
Brief 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
Detailed description
The patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group and control group. Experimental group: On the basis of conventional therapy,combined with xiyanping injection(andrographolide sulfonate) 10-20ml/d, with 0.9% normal saline 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops. control group: Xiyanping injection simulation(0.9% normal saline) 10-20ml/d,the treatment method is the same as the experimental group. Treatment cycle: less than 7 days (the longest period of treatment is 7 days, if the clinical symptoms were relieved in the treatment, patients were stoped treatment).
Interventions
Routine treatment for acute tonsillitis + Xiyanping injection
Routine treatment for acute tonsillitis + Xiyanping injection simulation
Sponsors
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Experimental group: Routine treatment for acute tonsillitis + Xiyanping injection Contral group: Routine treatment for acute tonsillitis + Xiyanping injection simulation(0.9% normal saline)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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' judgment, anyone who are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cured rate | less than 7 days | clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time from admission to recovery of sore throat | less than 7 days | the time of sore throat relief and purulent secretions complete disappearance of in the tonsils |
| time from admission to recovery of fever | less than 7 days | In the absence of other antipyretic drugs, the time from Xiyangping injection beganning to use to Axillary temperature below 37.5℃ , and last more than 24 hours without fever. |
| the incidence of complications | less than 7 days | Such as, the incidence of Acute otitis media, acute rhinitis, acute bronchitis, acute bronchitis,and so on. |
| effective time window | less than 7 days | days range from treatment is received to the effectiveness is observed, and symptoms disappear |
| days of antibiotic use | less than 7 days | oral anti infective Drugs use days and intravenous Anti infective Drugs use days are recorded |
| number of participants with treatment-related adverse events | less than 7 days | the total incidence of adverse events,the incidence of adverse events associated with Xiyanping injection, the incidence of patients with grade 3 through grade 4 adverse events that are related to study drug, graded according to NCI-CTC V4.0 . Observe and record all adverse events and serious adverse events, including physical examination, vital signs, laboratory tests (Hematology, blood biochemistry, urine routine, stool routine), ECG changes and so on. |
| bacterial eradication rate | less than 7 days | bacterial eradication rate=Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100% |
Countries
China
Contacts
Primary ContactLang Lv
Outcome results
None listed