Back to resultsA Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis
Primary Purpose
Acute Exacerbation of Chronic Bronchitis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
andrographolide sulfonate
andrographolide sulfonate simulation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Exacerbation of Chronic Bronchitis
Eligibility Criteria
Inclusion Criteria:
- 1.18-75 years, males or females;
- 2.patients met the acute exacerbation of chronic bronchitis diagnosis;
- 3.Patients with bronchitis were acute attacked 2-6 days,who had a history of chronic bronchitis more than 2 years.
- 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
Conventional Therapy + Xiyanping injection(andrographolide sulfonate)
Conventional Therapy + Xiyanping injection simulation/andrographolide sulfonate simulation(0.9% normal saline)
Outcomes
Primary Outcome Measures
cured rate
clinical symptoms(fever, cough, expectoration and gasp) and signs totally disappear, the period of lab tests（WBC,CRP, chest X-ray） 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 (fever, cough, expectoration and gasp).
days of antibiotic use
oral anti infective drugs use days and intravenous anti infective drugs use days are recorded
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%
=Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100%
direct medical cost
medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital
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
NCT ID
NCT03132610
First Posted
April 13, 2017
Last Updated
April 26, 2017
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03132610
Brief Title
A Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis
Official Title
Efficacy and Safety of Combined With Andrographolide Sulfonate on the Basis of Conventional Therapy in Patients With Acute Exacerbation of Chronic Bronchitis: 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 1, 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 exacerbation of chronic bronchitis
Detailed Description
The patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group or control group. Experimental group: on the basis of Conventional Therapy,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: on the basis of Conventional Therapy,Xiyanping injection simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of Chronic Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
Conventional Therapy + Xiyanping injection(andrographolide sulfonate)
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Conventional Therapy + Xiyanping injection simulation/andrographolide sulfonate simulation(0.9% normal saline)
Intervention Type
Drug
Intervention Name(s)
andrographolide sulfonate
Other Intervention Name(s)
Xiyanping injection
Intervention Description
Conventional Therapy+Xiyanping injection
Intervention Type
Drug
Intervention Name(s)
andrographolide sulfonate simulation
Other Intervention Name(s)
Xiyanping injection simulation
Intervention Description
Conventional Therapy+Xiyanping injection simulation
Primary Outcome Measure Information:
Title
cured rate
Description
clinical symptoms(fever, cough, expectoration and gasp) and signs totally disappear, the period of lab tests（WBC,CRP, chest X-ray） return to normal is recorded。
Time Frame
less than 14 days
Secondary Outcome Measure Information:
Title
effective time window
Description
days range from treatment is received to the effectiveness is observed, and symptoms disappear (fever, cough, expectoration and gasp).
Time Frame
less than 14 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 14 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 14 days
Title
bacterial eradication rate
Description
bacterial eradication rate=Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100%
=Sputum culture negative cases after treatment /sputum culture positive cases before treatment x 100%
Time Frame
less than 14 days
Title
direct medical cost
Description
medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital
Time Frame
less than 14 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 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.18-75 years, males or females;
2.patients met the acute exacerbation of chronic bronchitis diagnosis;
3.Patients with bronchitis were acute attacked 2-6 days,who had a history of chronic bronchitis more than 2 years.
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
First Name & Middle Initial & Last Name & Degree
Ping Xu
Organizational Affiliation
The Fourth 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
Learn more about this trial
A Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis
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