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

Primary Purpose

Acute Tonsillitis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Andrographolide sulfonate
Andrographolide sulfonate simulation
Sponsored by
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Tonsillitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Nanchang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

cured rate
clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded

Secondary Outcome Measures

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

Full Information

First Posted
April 12, 2017
Last Updated
April 27, 2017
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03134443
Brief Title
Evaluate the Efficacy and Safety of Andrographolide Sulfonate in Patients With Acute Tonsillitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
June 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

4. Oversight

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Tonsillitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Masking
Participant
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Xiyanping injection simulation(andrographolide sulfonate simulation) 10-20ml/d, The treatment method is the same as the experimental group.
Intervention Type
Drug
Intervention Name(s)
Andrographolide sulfonate
Other Intervention Name(s)
Xiyanping injection
Intervention Description
Routine treatment for acute tonsillitis + Xiyanping injection
Intervention Type
Drug
Intervention Name(s)
Andrographolide sulfonate simulation
Other Intervention Name(s)
Xiyanping injection simulation
Intervention Description
Routine treatment for acute tonsillitis + Xiyanping injection simulation
Primary Outcome Measure Information:
Title
cured rate
Description
clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded
Time Frame
less than 7 days
Secondary Outcome Measure Information:
Title
effective time window
Description
days range from treatment is received to the effectiveness is observed, and symptoms disappear
Time Frame
less than 7 days
Title
time from admission to recovery of sore throat
Description
the time of sore throat relief and purulent secretions complete disappearance of in the tonsils
Time Frame
less than 7 days
Title
time from admission to recovery of fever
Description
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.
Time Frame
less than 7 days
Title
the incidence of complications
Description
Such as, the incidence of Acute otitis media, acute rhinitis, acute bronchitis, acute bronchitis,and so on.
Time Frame
less than 7 days
Title
bacterial eradication rate
Description
bacterial eradication rate=Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100%
Time Frame
less than 7 days
Title
days of antibiotic use
Description
oral anti infective Drugs use days and intravenous Anti infective Drugs use days are recorded
Time Frame
less than 7 days
Title
number of participants with treatment-related adverse events
Description
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.
Time Frame
less than 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lang Lv
Phone
+86 010-84682600
Email
bjlll@qfyy.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang
Organizational Affiliation
The First Affiliated Hospital of Nanchang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhang
Phone
+86 0790-88694316

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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