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

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ClinicalTrials.gov Identifier: NCT03132623
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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

Condition or disease Intervention/treatment Phase
Acute 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: 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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Andrographolide Sulfonate in the Treatment of Acute Bronchitis: a Randomized,Double-blind,Placebo Parallel Controlled,Multicenter Study
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : December 30, 2017
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.
Other Name: Xiyanping injection

Placebo Comparator: control group
andrographolide sulfonate simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.
Drug: andrographolide sulfonate simulation
Xiyanping injection simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.
Other Name: Xiyanping injection simulation




Primary Outcome Measures :
  1. cured rate [ Time Frame: less than 7 days ]
    clinical symptoms(fever, cough) and signs(pulmonary rales) totally disappear, the period of lab tests return to normal is recorded


Secondary Outcome Measures :
  1. effective time window [ Time Frame: less than 7 days ]
    days range from treatment is received to the effectiveness is observed, and symptoms disappear

  2. time from admission to recovery of fever [ Time Frame: less than 7 days ]
    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.

  3. the incidence of complications [ Time Frame: less than 7 days ]
    Such as, the incidence of Pneumonia, chronic bronchitis, bronchiectasis,and so on.

  4. days of Anti infective Drugs use [ Time Frame: less than 7 days ]
    oral anti infective Drugs use days and intravenous Anti infective Drugs use days are recorded

  5. number of participants with treatment-related adverse events [ Time Frame: less than 7 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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 ClinicalTrials.gov identifier (NCT number): NCT03132623


Contacts
Contact: Lang Lv +86 010-84682600 bjlll@qfyy.com.cn
Contact: Ting Zhao +86 0755-23901849 6648390@qq.com

Locations
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.
Investigators
Study Chair: Wei Zhang The First Affiliated Hospital of Nanchang University
Study Director: Ping Xu The Fourth Affiliated Hospital of Nanchang University
Study Director: Weiyou Liu The 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

Responsible Party: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT03132623     History of Changes
Other Study ID Numbers: JXQF-XYP-1609
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Andrographolide
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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