Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG NPP709 Syrup

Study Overview
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Brief Summary
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The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to evaluate the safety and efficacy in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis.

Official Title
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Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG NPP709 Syrup in Acute Upper Respiratory Tract Infection and Chronic Inflammatory Bronchitis Patients: Double Blinded, Randomized, Active Drug Comparative, Parallel Designed, Multi-centered, Phase III Study

Conditions
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Acute Upper Respiratory Tract Infections, Bronchitis

Intervention / Treatment
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* Drug: AG NPP709syrup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent s or patient who decided to participate in this clinical trial at his (her) own will and agreed in written letter of consent Patient ages between 24months and 75years Patient with a clinical diagnosis of acute upper respiratory tract infection or chronic inflammatory bronchitis should has any combination of at least two of following symptoms including sputum: cough, sputum, dyspnea and chest pain when breathing Females of child-bearing age should have nagative pregnancy test or have sufficient contraceptive protection Exclusion Criteria: Patient whose the following severe respiratory disease: pneumonia, uncontrolled asthma, pancreatic fibrosis viral influenza, tuberculosis Patient whose the following disease: malignant tumors, severe central nervous system disorders, medication needed severe metabolic disorders Patient whose fructose intolerance Patient who has hypersensitivity anamnesis of Prospan syrup Patient whose heart function is abnormal: cardiac insufficiency, including the case of showing abnormal EKG test value that is clinically significant Patient whose liver or kidney function is serious abnormal: including the cases of ALT, AST, bilirubin and blood creatinine value exceeding three times of their upper limit, severe liver disorders, chronic kidney disease Patient who has uncontrolled diabetes or uncontrolled hypertensions Patient who has experience to have participated in other clinical trial within two months before starting the trial Pregnant women, lactating women

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AG NPP709 syrup<br>AG NPP709 contains Ivy leaf extract and coptis rhizoma extract | Drug: AG NPP709syrup<br> <br> |
| Active Comparator: Ivy leaf extract syrup<br> | Drug: AG NPP709syrup<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement by global assessment | At closing visit, researcher assess clinical efficacy using the following five criteria (4: cure, 3: significant improvement, 2: improvement, 1: some improvement, 0: non-improvement or worsening of symptoms). Upper the Grade 3 outcomes are defined as clinical success. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine safety by unwanted reaction, clinical laboratory test and physical examination |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute upper respiratory tract infection, chronic inflamatory bronchitis