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

Ahn-Gook Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acute Upper Respiratory Tract Infections; Bronchitis

Treatments: Drug: AG NPP709syrup

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01151202

AG NPP_P3

Details and patient eligibility

About

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.

Enrollment: 236 patients

Sex: All

Ages: 24 months to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Parent s or patient who decided to participate in this clinical trial at his (her) own will and agreed in written letter of consent
2. Patient ages between 24months and 75years
3. 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
4. Females of child-bearing age should have nagative pregnancy test or have sufficient contraceptive protection

Exclusion criteria

1. Patient whose the following severe respiratory disease: pneumonia, uncontrolled asthma, pancreatic fibrosis viral influenza, tuberculosis
2. Patient whose the following disease: malignant tumors, severe central nervous system disorders, medication needed severe metabolic disorders
3. Patient whose fructose intolerance
4. Patient who has hypersensitivity anamnesis of Prospan syrup
5. Patient whose heart function is abnormal: cardiac insufficiency, including the case of showing abnormal EKG test value that is clinically significant
6. 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
7. Patient who has uncontrolled diabetes or uncontrolled hypertensions
8. Patient who has experience to have participated in other clinical trial within two months before starting the trial
9. Pregnant women, lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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236 participants in 2 patient groups

AG NPP709 syrup

Experimental group

Description:

AG NPP709 contains Ivy leaf extract and coptis rhizoma extract

Treatment:

Drug: AG NPP709syrup

Ivy leaf extract syrup

Active Comparator group

Treatment:

Drug: AG NPP709syrup