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

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

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

Study Overview

• Status: Unknown
• Conditions: Acute Tonsillitis
• Intervention / Treatment: Drug: Andrographolide sulfonate; Drug: Andrographolide sulfonate simulation

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).

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Recruiting
      • The first affiliated Hospital of Nanchang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Xiyanping injection simulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effective time window	days range from treatment is received to the effectiveness is observed, and symptoms disappear	less than 7 days
time from admission to recovery of sore throat	the time of sore throat relief and purulent secretions complete disappearance of in the tonsils	less than 7 days
time from admission to recovery of fever	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.	less than 7 days
the incidence of complications	Such as, the incidence of Acute otitis media, acute rhinitis, acute bronchitis, acute bronchitis,and so on.	less than 7 days
bacterial eradication rate	bacterial eradication rate=Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100%	less than 7 days
days of antibiotic use	oral anti infective Drugs use days and intravenous Anti infective Drugs use days are recorded	less than 7 days
number of participants with treatment-related adverse events	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.	less than 7 days

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Suppuration; Pharyngitis; Abscess; Tonsillitis; Peritonsillar Abscess; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Platelet Aggregation Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Andrographolide
• Other Study ID Numbers: JXQF-XYP-1610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided