Evaluate the Efficacy and Safety of Andrographolide Sulfonate in Patients With Acute Bronchitis
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|ClinicalTrials.gov Identifier: NCT03132623|
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : May 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Bronchitis||Drug: andrographolide sulfonate Drug: andrographolide sulfonate simulation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy and Safety of Andrographolide Sulfonate in the Treatment of Acute Bronchitis: a Randomized,Double-blind,Placebo Parallel Controlled,Multicenter Study|
|Actual Study Start Date :||December 1, 2016|
|Estimated Primary Completion Date :||December 30, 2017|
|Estimated Study Completion Date :||June 1, 2018|
Active Comparator: Experimental group
andrographolide sulfonate(Xiyanping injection) 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.
Drug: andrographolide sulfonate
Xiyanping injection 10-20ml/d, With 0.9% Sodium Chloride Injection 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops.
Other Name: Xiyanping injection
Placebo Comparator: control group
andrographolide sulfonate simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.
Drug: andrographolide sulfonate simulation
Xiyanping injection simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.
Other Name: Xiyanping injection simulation
- 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
- 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.
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): NCT03132623
|Contact: Lang Lv||+86 firstname.lastname@example.org|
|Contact: Ting Zhao||+86 email@example.com|
|The First Affiliated Hospital of Nanchang University||Recruiting|
|Nanchang, Jiangxi, China, 330029|
|Contact: Wei Zhang +86 0790-88694316|
|Study Chair:||Wei Zhang||The First Affiliated Hospital of Nanchang University|
|Study Director:||Ping Xu||The Fourth Affiliated Hospital of Nanchang University|
|Study Director:||Weiyou Liu||The First Affiliated Hospital of Gannan Medical University|
|Study Director:||Jun Li||Jiujiang First People's Hospital|
|Study Director:||Xianghua Zhang||First Hospital of Shijiazhuang City|