Clinical Trial: A Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis

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

Official Title: Efficacy and Safety of Combined With Andrographolide Sulfonate on the Basis of Conventional Therapy in Patients With Acute Exacerbation of Chronic Bronchitis: a Randomized

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 exacerbation of chronic 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: 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.
Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Current Primary Outcome: cured rate [ Time Frame: less than 14 days ]

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。


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • effective time window [ Time Frame: less than 14 days ]
    days range from treatment is received to the effectiveness is observed, and symptoms disappear (fever, cough, expectoration and gasp).
  • days of antibiotic use [ Time Frame: less than 14 days ]
    oral anti infective drugs use days and intravenous anti infective drugs use days are recorded
  • the incidence of complications [ Time Frame: less than 14 days ]
    such as, the incidence of Acute otitis media, acute rhinitis, acute bronchitis, acute bronchitis, and so on.
  • bacterial eradication rate [ Time Frame: less than 14 days ]

    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%

  • direct medical cost [ Time Frame: less than 14 days ]
    medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital
  • number of participants with treatment-related adverse events [ Time Frame: less than 14 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: Same as current

Information By: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Dates:
Date Received: April 13, 2017
Date Started: December 1, 2016
Date Completion: June 1, 2018
Last Updated: April 26, 2017
Last Verified: April 2017