A study for the efficacy and safety of health foods extracts in promoting respiratory health

A trial to study the efficacy and safety of HX 110-A and HX 110-B in promoting respiratory health : 8-week, randomized, double-blind, parallel group, placebo-controlled design

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0003614

Enrollment

Registered

2019-03-12

Start date

2019-02-07

Completion date

Unknown

Last updated

2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(health supplement) : 8-week randomized double-blind parrelel study. placebo vs. intervention 1 (HX 100-A) vs. intervention 2 (HX 100-B) test substance: HX110-A or HX110-B 500 mg tablet 1tab bi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: person with 1) confirmed consent 2) age >= 40 years old 3) persistent respiratory symptoms including cough and sputum 4) following the restriction dietary schedule during study period

Exclusion criteria

Exclusion criteria: person with 1) respiratory diseases including acute bronchitis, chronic bronchitis (BCSS score >=3 & chronic sputum/cough more than 3 months in subsequent years), pneumonia, tuberculosis, bronchial asthma, COPD, lung cancer 2) Diabetes, cardiovascular diseases except hypertension 3) taking antioxidants or antifilammatory drugs within recent 6weeks 4) serum creatinine = 2 mg/dL or ESRD 5) total bilirubin = 2 mg/dL or AST or ALT = 1.5 x normal value 6) uncontrolled psychologic disease or alcoholics 7) taking heath promoting foods with anti-oxidant activity (RFS score>36) 8) BMI >=35kg/m2 9) history of hypersensitivity for testing substance 10) involving other clinical trials within 1month 11) pregancy or lactating status 12) the investigator's decision

Design outcomes

Primary

Measure	Time frame
total antioxidative capacity;respiratory symptom scores including BCSS, VAS, CASA-Q, COAT;inflammatory markers including sRAGE, SP-D, CC-16, CRP, FENO	—

Secondary

Measure	Time frame
Quality of life (EuroQoL-5D, EQ-5D), Fatiguee symptom score (FSS)	—

Countries

Korea, Republic of

Contacts

Public ContactYoungRan Hwang

Seoul Metropolitan Government Seoul National University Boramae Medical Center

yrwhang@gmail.com+82-2-870-2878

Outcome results