- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03132623
Evaluate the Efficacy and Safety of Andrographolide Sulfonate in Patients With Acute Bronchitis
The Efficacy and Safety of Andrographolide Sulfonate in the Treatment of Acute Bronchitis: a Randomized,Double-blind,Placebo Parallel Controlled,Multicenter Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Ting Zhao
- Phone Number: +86 0755-23901849
- Email: 6648390@qq.com
Study Locations
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330029
- Recruiting
- The First Affiliated Hospital of NanChang University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
PLACEBO_COMPARATOR: control group
andrographolide sulfonate simulation(0.9%
normal saline) 10-20ml/d, The treatment method is the same as the experimental group.
|
Xiyanping injection simulation(0.9%
normal saline) 10-20ml/d, The treatment method is the same as the experimental group.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
less than 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effective time window
Time Frame: less than 7 days
|
days range from treatment is received to the effectiveness is observed, and symptoms disappear
|
less than 7 days
|
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.
|
less than 7 days
|
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. |
less than 7 days
|
the incidence of complications
Time Frame: less than 7 days
|
Such as, the incidence of Pneumonia, chronic bronchitis, bronchiectasis,and so on.
|
less than 7 days
|
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
|
less than 7 days
|
Collaborators and Investigators
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Bronchial Diseases
- Lung Diseases, Obstructive
- Acute Disease
- Bronchitis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Platelet Aggregation Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Andrographolide
Other Study ID Numbers
- JXQF-XYP-1609
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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