Evaluate the Efficacy and Safety of Andrographolide Sulfonate in Patients With Acute Tonsillitis

Overview

A multicenter, randomized, single-blind, placebo-controlled,phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute tonsillitis

Full Title of Study: “Combined With Andrographolide Sulfonate on the Basis of Conventional Therapy in the Treatment of Acute Tonsillitis: a Randomized, Single Blind, Placebo-controlled, Multicenter Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2017

Detailed Description

The patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group and control group. Experimental group: On the basis of conventional therapy,combined with 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% normal saline) 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).

Interventions

  • Drug: Andrographolide sulfonate
    • Routine treatment for acute tonsillitis + Xiyanping injection
  • Drug: Andrographolide sulfonate simulation
    • Routine treatment for acute tonsillitis + Xiyanping injection simulation

Arms, Groups and Cohorts

  • 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.
  • Placebo Comparator: control group
    • Xiyanping injection simulation(andrographolide sulfonate simulation) 10-20ml/d, The treatment method is the same as the experimental group.

Clinical Trial Outcome Measures

Primary Measures

  • cured rate
    • Time Frame: less than 7 days
    • clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • 1.18-65 years, males or females; – 2.patients met the acute tonsillitis diagnosis; – 3.patients'all symptoms (including cough) appeared no longer than 72 h before inclusion to the trial – 4.patients compliance is good, written informed consent was obtained from all participants before the study. Exclusion Criteria:
  • 1.Patients had a history of andrographolide sulfonate or andrographolide allergy. – 2.Pregnancy, lactation, and absence of contraception in women of fertile age. – 3.Judging by the researchers, Past or present illness of patients may affect to participate in the trial or affect the outcome of the study, including cardio-pulmonary diseases, malignant diseases, autoimmune diseases, hepatorenal disease, blood diseases, nervous system diseases, immune system diseases and endocrine diseases. – 4.After checking, Patients with pulmonary tuberculosis, bronchial asthma, bronchial pneumonia, bronchiectasis, pneumoconiosis, silicosis, lung cancer, pulmonary infiltration or other allergic respiratory diseases and other chronic lung diseases – 5.Patients using systemic steroids or other immunosuppressive therapy – 6.Patients with severe cardiopulmonary dysfunction, abnormal liver and kidney function, blood system diseases. – 7.Patients are alcohol (daily drink alcoholic wine is more than 40g) or drug abuse or drug addicts in the past year. – 8.Patients were participated in any study of drug trials in the last 30 days. – 9.According to the researchers' judgment, anyone who are not suitable for the study.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 65 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Jiangxi Qingfeng Pharmaceutical Co. Ltd.
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Wei Zhang, Principal Investigator, The First Affiliated Hospital of Nanchang University
    • Overall Contact(s)
      • Lang Lv, +86 010-84682600, bjlll@qfyy.com.cn

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