Clinical Trial: Evaluate the Efficacy and Safety of Andrographolide Sulfonate in Patients With Acute Bronchitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Efficacy and Safety of Andrographolide Sulfonate in the Treatment of Acute Bronchitis: a Randomized,Double-blind,Placebo Parallel Controlled,Multicenter Study

Brief Summary: A multicenter, randomized, double-blind, placebo-controlled, phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute bronchitis

Detailed Summary: The patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group or control group. Experimental group: 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% Sodium Chloride Injection) 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).
Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Current Primary Outcome: cured rate [ Time Frame: less than 7 days ]

clinical symptoms(fever, cough) and signs(pulmonary rales) totally disappear, the period of lab tests return to normal is recorded


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • effective time window [ Time Frame: less than 7 days ]
    days range from treatment is received to the effectiveness is observed, and symptoms disappear
  • time from admission to recovery of fever [ Time Frame: 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 [ Time Frame: less than 7 days ]
    Such as, the incidence of Pneumonia, chronic bronchitis, bronchiectasis,and so on.
  • days of Anti infective Drugs use [ Time Frame: 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 [ Time Frame: 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.



Original Secondary Outcome:

  • effective time window [ Time Frame: less than 7 days ]

    days range from treatment is received to the effectiveness is observed, and symptoms disappear 2. the incidence of adverse events associated with Xiyanping injection. 3. 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 from admission to recovery of fever [ Time Frame: 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 [ Time Frame: less than 7 days ]
    Such as, the incidence of Pneumonia, chronic bronchitis, bronchiectasis,and so on.
  • days of Anti infective Drugs use [ Time Frame: 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 [ Time Frame: 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.



Information By: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Dates:
Date Received: April 11, 2017
Date Started: December 1, 2016
Date Completion: June 1, 2018
Last Updated: April 27, 2017
Last Verified: April 2017