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
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
144
Routine treatment for acute tonsillitis + Xiyanping injection
Routine treatment for acute tonsillitis + Xiyanping injection simulation
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGcured rate
clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded
Time frame: less than 7 days
effective time window
days range from treatment is received to the effectiveness is observed, and symptoms disappear
Time frame: less than 7 days
time from admission to recovery of sore throat
the time of sore throat relief and purulent secretions complete disappearance of in the tonsils
Time frame: less than 7 days
time from admission to recovery of fever
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.
Time frame: less than 7 days
the incidence of complications
Such as, the incidence of Acute otitis media, acute rhinitis, acute bronchitis, acute bronchitis,and so on.
Time frame: less than 7 days
bacterial eradication rate
bacterial eradication rate=Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100%
Time frame: less than 7 days
days of antibiotic use
oral anti infective Drugs use days and intravenous Anti infective Drugs use days are recorded
Time frame: less than 7 days
number of participants with treatment-related adverse events
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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.
Time frame: less than 7 days