A Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis

NCT ID: NCT03132610

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Exacerbation of Chronic Bronchitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

Conventional Therapy + Xiyanping injection(andrographolide sulfonate)

Group Type ACTIVE_COMPARATOR

andrographolide sulfonate

Intervention Type DRUG

Conventional Therapy+Xiyanping injection

control group

Conventional Therapy + Xiyanping injection simulation/andrographolide sulfonate simulation(0.9% normal saline)

Group Type PLACEBO_COMPARATOR

andrographolide sulfonate simulation

Intervention Type DRUG

Conventional Therapy+Xiyanping injection simulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

andrographolide sulfonate

Conventional Therapy+Xiyanping injection

Intervention Type DRUG

andrographolide sulfonate simulation

Conventional Therapy+Xiyanping injection simulation

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Xiyanping injection Xiyanping injection simulation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wei Zhang

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Nanchang University

Ping Xu

Role: PRINCIPAL_INVESTIGATOR

The Fourth Affiliated Hospital of Nanchang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lang Lv

Role: CONTACT

Phone: +86 010-84682600

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wei Zhang

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JXQF-XYP-1608

Identifier Type: -

Identifier Source: org_study_id