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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03132610
Recruitment Status : Unknown
Verified April 2017 by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
Recruitment status was:  Recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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

Condition or disease Intervention/treatment Phase
Acute Exacerbation of Chronic Bronchitis Drug: andrographolide sulfonate Drug: andrographolide sulfonate simulation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Experimental group
Conventional Therapy + Xiyanping injection(andrographolide sulfonate)
Drug: andrographolide sulfonate
Conventional Therapy+Xiyanping injection
Other Name: Xiyanping injection

Placebo Comparator: control group
Conventional Therapy + Xiyanping injection simulation/andrographolide sulfonate simulation(0.9% normal saline)
Drug: andrographolide sulfonate simulation
Conventional Therapy+Xiyanping injection simulation
Other Name: Xiyanping injection simulation

Primary Outcome Measures :
  1. cured rate [ Time Frame: less than 14 days ]
    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 :
  1. effective time window [ Time Frame: less than 14 days ]
    days range from treatment is received to the effectiveness is observed, and symptoms disappear (fever, cough, expectoration and gasp).

  2. days of antibiotic use [ Time Frame: less than 14 days ]
    oral anti infective drugs use days and intravenous anti infective drugs use days are recorded

  3. the incidence of complications [ Time Frame: less than 14 days ]
    such as, the incidence of Acute otitis media, acute rhinitis, acute bronchitis, acute bronchitis, and so on.

  4. bacterial eradication rate [ Time Frame: less than 14 days ]

    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%

  5. direct medical cost [ Time Frame: less than 14 days ]
    medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital

  6. number of participants with treatment-related adverse events [ Time Frame: less than 14 days ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03132610

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Contact: Lang Lv +86 010-84682600

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China, Jiangxi
The First Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330029
Contact: Wei Zhang    +86 0790-88694316      
Sponsors and Collaborators
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
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Principal Investigator: Wei Zhang The First Affiliated Hospital of Nanchang University
Principal Investigator: Ping Xu The Fourth Affiliated Hospital of Nanchang University

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Responsible Party: Jiangxi Qingfeng Pharmaceutical Co. Ltd. Identifier: NCT03132610    
Other Study ID Numbers: JXQF-XYP-1608
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Bronchitis, Chronic
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiviral Agents
Platelet Aggregation Inhibitors