MedDataX Logo

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

NCT ID: NCT01151202

Last Updated: 2010-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Upper Respiratory Tract Infections Bronchitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AG NPP709 syrup

AG NPP709 contains Ivy leaf extract and coptis rhizoma extract

Group Type EXPERIMENTAL

AG NPP709syrup

Intervention Type DRUG

Ivy leaf extract syrup

Group Type ACTIVE_COMPARATOR

AG NPP709syrup

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AG NPP709syrup

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

24 Months

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kyunghee University Medical Center

OTHER

Sponsor Role collaborator

Inha University Hospital

OTHER

Sponsor Role collaborator

Ewha Womans University

OTHER

Sponsor Role collaborator

Hanyang University

OTHER

Sponsor Role collaborator

Konkuk University Medical Center

OTHER

Sponsor Role collaborator

Ahn-Gook Pharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahn-Gook Pharmaceutical Co., Ltd

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Young-ho Na, PhD, MD

Role: STUDY_DIRECTOR

Kyung Hee University Medical Center, Department of Pediatrics,

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Inha University Hospital, Department of Pediatrics

Incheon, , South Korea

Site Status

Ewha Womens University Medical Center Mokdong Hospital, Department of Allergology

Seoul, , South Korea

Site Status

Hanyang University Medical Center, Department of Respiratory Medicine

Seoul, , South Korea

Site Status

Konkuk University Medical Center, Department of Respiratory Medicine

Seoul, , South Korea

Site Status

Kyung Hee University International Medical Service, Department of Pediatrics

Seoul, , South Korea

Site Status

Kyung Hee University Medical Center, Department of Pediatrics,

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AG NPP_P3

Identifier Type: -

Identifier Source: org_study_id