A multicenter,randomized,single-blind, placebo-controlled,phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute exacerbation of chronic bronchitis
The patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group or control group. Experimental group: on the basis of Conventional Therapy,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: on the basis of Conventional Therapy,Xiyanping injection simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
Conventional Therapy+Xiyanping injection
Conventional Therapy+Xiyanping injection simulation
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGcured rate
clinical symptoms(fever, cough, expectoration and gasp) and signs totally disappear, the period of lab tests(WBC,CRP, chest X-ray) return to normal is recorded。
Time frame: less than 14 days
effective time window
days range from treatment is received to the effectiveness is observed, and symptoms disappear (fever, cough, expectoration and gasp).
Time frame: less than 14 days
days of antibiotic use
oral anti infective drugs use days and intravenous anti infective drugs use days are recorded
Time frame: less than 14 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 14 days
bacterial eradication rate
bacterial eradication rate=Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100% =Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100%
Time frame: less than 14 days
direct medical cost
medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital
Time frame: less than 14 days
number of participants with treatment-related adverse events
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: less than 14 days