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

NCT03132623 | Unknown Phase 4

• 1 other identifier: JXQF-XYP-1609
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

• cured rate

  clinical symptoms(fever, cough) and signs(pulmonary rales) totally disappear, the period of lab tests return to normal is recorded

  less than 7 days

Secondary Outcomes (5)

• effective time window

  less than 7 days

• time from admission to recovery of fever

  less than 7 days

• the incidence of complications

  less than 7 days

• days of Anti infective Drugs use

  less than 7 days

• number of participants with treatment-related adverse events

  less than 7 days

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

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.

Drug: andrographolide sulfonate

control group

PLACEBO COMPARATOR

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

Drug: andrographolide sulfonate simulation

Interventions

andrographolide sulfonate 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.

Also known as: Xiyanping injection

Experimental group

andrographolide sulfonate simulation DRUG

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

Also known as: Xiyanping injection simulation

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years, males or females;
• patients met the acute bronchitis diagnosis;
• patients compliance is good, written informed consent was obtained from all participants before the study.

You may not qualify if:

• Patients had a history of andrographolide sulfonate or andrographolide allergy.
• pregnancy, lactation, and absence of contraception in women of fertile age.
• 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.
• 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
• Patients using systemic steroids or other immunosuppressive therapy
• Patients with severe cardiopulmonary dysfunction, abnormal liver and kidney function, blood system diseases.
• Patients are alcohol (daily drink alcoholic wine is more than 40g) or drug abuse or drug addicts in the past year.
• Patients were participated in any study of drug trials in the last 30 days.
• According to the researchers' judgment, anyone who are not suitable for the study.

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330029, China

RECRUITING

MeSH Terms

Conditions

Bronchitis

Interventions

andrographolide sulfonate

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Wei Zhang

  The First Affiliated Hospital of Nanchang University

  STUDY CHAIR

• Ping Xu

  The Fourth Affiliated Hospital of Nanchang University

  STUDY DIRECTOR

• Weiyou Liu

  First Affiliated Hospital of Gannan Medical University

  STUDY DIRECTOR

• Jun Li

  Jiujiang First People's Hospital

  STUDY DIRECTOR

• Xianghua Zhang

  First Hospital of Shijiazhuang City

  STUDY DIRECTOR

Central Study Contacts

Lang Lv

CONTACT

+86 010-84682600; bjlll@qfyy.com.cn

Ting Zhao

CONTACT

+86 0755-23901849; 6648390@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 28, 2017
• Study Start: December 1, 2016
• Primary Completion: December 30, 2017
• Study Completion: June 1, 2018
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

CN (1)