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

Primary Purpose

Acute Bronchitis

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

andrographolide sulfonate

andrographolide sulfonate simulation

About this trial

This is an interventional treatment trial for Acute Bronchitis

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 bronchitis 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

andrographolide sulfonate(Xiyanping injection) 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.

andrographolide sulfonate simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.

Outcomes

Primary Outcome Measures

cured rate

clinical symptoms(fever, cough) and signs(pulmonary rales) 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 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 Pneumonia, chronic bronchitis, bronchiectasis,and so on.

days of Anti infective Drugs 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

NCT ID

NCT03132623

First Posted

April 11, 2017

Last Updated

April 27, 2017

Sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03132623

Brief Title

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

Official Title

The Efficacy and Safety of Andrographolide Sulfonate in the Treatment of Acute Bronchitis: a Randomized,Double-blind,Placebo Parallel 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 30, 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

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

A multicenter, randomized, double-blind, placebo-controlled, phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute 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: 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% Sodium Chloride Injection) 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 Bronchitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Active Comparator

Arm Description

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

andrographolide sulfonate simulation(0.9% normal saline) 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

Xiyanping injection 10-20ml/d, With 0.9% Sodium Chloride Injection 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops.

Intervention Type

Drug

Intervention Name(s)

andrographolide sulfonate simulation

Other Intervention Name(s)

Xiyanping injection simulation

Intervention Description

Xiyanping injection simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.

Primary Outcome Measure Information:

Title

cured rate

Description

clinical symptoms(fever, cough) and signs(pulmonary rales) 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 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 Pneumonia, chronic bronchitis, bronchiectasis,and so on.

Time Frame

less than 7 days

Title

days of Anti infective Drugs 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

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

Eligibility Criteria

Inclusion Criteria: 1.18-65 years, males or females; 2.patients met the acute bronchitis 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

bjlll@qfyy.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Ting Zhao

Phone

+86 0755-23901849

6648390@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Zhang

Organizational Affiliation

The First Affiliated Hospital of Nanchang University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ping Xu

Organizational Affiliation

The Fourth Affiliated Hospital of Nanchang University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Weiyou Liu

Organizational Affiliation

The First Affiliated Hospital of Gannan Medical University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jun Li

Organizational Affiliation

Jiujiang First People's Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Xianghua Zhang

Organizational Affiliation

First Hospital of Shijiazhuang City

Official's Role

Study Director

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 Bronchitis

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