Evaluate the Efficacy and Safety of Andrographolide Sulfonate in Patients With Acute Tonsillitis
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|ClinicalTrials.gov Identifier: NCT03134443|
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : May 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Tonsillitis||Drug: Andrographolide sulfonate Drug: Andrographolide sulfonate simulation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Experimental group: Routine treatment for acute tonsillitis + Xiyanping injection Contral group: Routine treatment for acute tonsillitis + Xiyanping injection simulation(0.9% normal saline)|
|Official Title:||Combined With Andrographolide Sulfonate on the Basis of Conventional Therapy in the Treatment of Acute Tonsillitis: a Randomized, Single Blind, Placebo-controlled, Multicenter Study|
|Actual Study Start Date :||December 1, 2016|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||June 1, 2018|
Active Comparator: 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.
Drug: Andrographolide sulfonate
Routine treatment for acute tonsillitis + Xiyanping injection
Other Name: Xiyanping injection
Placebo Comparator: control group
Xiyanping injection simulation(andrographolide sulfonate simulation) 10-20ml/d, The treatment method is the same as the experimental group.
Drug: Andrographolide sulfonate simulation
Routine treatment for acute tonsillitis + Xiyanping injection simulation
Other Name: Xiyanping injection simulation
- cured rate [ Time Frame: less than 7 days ]clinical symptoms and signs 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 sore throat [ Time Frame: less than 7 days ]the time of sore throat relief and purulent secretions complete disappearance of in the tonsils
- 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 Acute otitis media, acute rhinitis, acute bronchitis, acute bronchitis,and so on.
- bacterial eradication rate [ Time Frame: less than 7 days ]bacterial eradication rate=Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100%
- days of antibiotic 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): NCT03134443
|Contact: Lang Lv||+86 firstname.lastname@example.org|
|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|