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

NCT ID: NCT03132623

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2018-06-01

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).

Conditions

Acute Bronchitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group

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.

Group Type: ACTIVE_COMPARATOR

andrographolide sulfonate

Intervention Type: DRUG

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.

control group

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

Group Type: PLACEBO_COMPARATOR

andrographolide sulfonate simulation

Intervention Type: DRUG

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

Interventions

andrographolide sulfonate

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

andrographolide sulfonate simulation

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

Intervention Type: DRUG

Other Intervention Names

Xiyanping injection; Xiyanping injection simulation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Zhang

Role: STUDY_CHAIR

The First Affiliated Hospital of Nanchang University

Ping Xu

Role: STUDY_DIRECTOR

The Fourth Affiliated Hospital of Nanchang University

Weiyou Liu

Role: STUDY_DIRECTOR

First Affiliated Hospital of Gannan Medical University

Jun Li

Role: STUDY_DIRECTOR

Jiujiang First People's Hospital

Xianghua Zhang

Role: STUDY_DIRECTOR

First Hospital of Shijiazhuang City

Locations

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lang Lv

Role: CONTACT

bjlll@qfyy.com.cn

+86 010-84682600

Ting Zhao

Role: CONTACT

6648390@qq.com

+86 0755-23901849

Facility Contacts

Wei Zhang

Role: primary

+86 0790-88694316

Other Identifiers

JXQF-XYP-1609

Identifier Type: -

Identifier Source: org_study_id