A Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis
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|ClinicalTrials.gov Identifier: NCT03132610|
Recruitment Status : Unknown
Verified April 2017 by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
Recruitment status was: Recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Exacerbation of Chronic Bronchitis||Drug: andrographolide sulfonate Drug: andrographolide sulfonate simulation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|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, Single Blind, Placebo-controlled, Multicenter Study|
|Actual Study Start Date :||December 1, 2016|
|Estimated Primary Completion Date :||December 1, 2017|
|Estimated Study Completion Date :||June 1, 2018|
Active Comparator: Experimental group
Conventional Therapy + Xiyanping injection(andrographolide sulfonate)
Drug: andrographolide sulfonate
Conventional Therapy+Xiyanping injection
Other Name: Xiyanping injection
Placebo Comparator: control group
Conventional Therapy + Xiyanping injection simulation/andrographolide sulfonate simulation(0.9% normal saline)
Drug: andrographolide sulfonate simulation
Conventional Therapy+Xiyanping injection simulation
Other Name: Xiyanping injection simulation
- 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。
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132610
|Contact: Lang Lv||+86 email@example.com|
|The First Affiliated Hospital of Nanchang University||Recruiting|
|Nanchang, Jiangxi, China, 330029|
|Contact: Wei Zhang +86 0790-88694316|
|Principal Investigator:||Wei Zhang||The First Affiliated Hospital of Nanchang University|
|Principal Investigator:||Ping Xu||The Fourth Affiliated Hospital of Nanchang University|