임상연구정보서비스

Search: Search

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 Approved

First Submitted Date

2019/02/14
Registered Date

2019/03/12
Last Updated Date

2019/02/26

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003614
Unique Protocol ID	30-2018-90
Public/Brief Title	A study for the efficacy and safety of health foods extracts in promoting respiratory health
Scientific Title	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
Acronym	HX 110 PRESH
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	20181101 / 30 - 2018 - 90 / 113
Approval Date	2019-01-02
Institutional Review Board Name	Boramae Hospital Insutional Review Board
Institutional Review Board Address	20, Boramae-ro 5-gil, Dongjak-gu, Seoul
Institutional Review Board Telephone	02-870-1852
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	DEOG KYEOM KIM
Title	MD, PhD
Telephone	+82-2-870-2228
Affiliation	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Address	20 Boramaero-5-Gil, Donjak-Gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	YoungRan Hwang
Title	CRC
Telephone	+82-2-870-2878
Affiliation	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Address	20 Boramaero-5-Gil, Donjak-Gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	DEOG KYEOM KIM
Title	MD, PhD
Telephone	+82-2-870-2228
Affiliation	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Address	20 Boramaero-5-Gil, Donjak-Gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-02-07 Actual
Target Number of Participant	75
Primary Completion Date
Study Completion Date
Name of Study	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2019-02-07 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	ViroMed
Organization Type	Research Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	ViroMed
Organization Type	Research Institute

7. Study Summary

Study Summary Information
Lay Summary	Although respiratory disease is prevalent and may lead to high mortality, it tends to be detected in late status of the disease and the reversibility may be small. As a result, current therapeutic trials in respiratory diseases show small effect in improving respiratory health. It is why the prevention or promoting respiratory health is important to minimizing the risk of respiratory disease. This study is aimed to improve respiratory health by using compounds of health promotion foods in terms of respiratory symptoms, symptom scores, and attenuation of various inflammatory or oxidant stress. HX 100-A and -B are a kinds of health promotion foods containing Dioscorea polystachya, Adenophora triphylla etc., which are traditionally used to attenuate cough, sputum, and inflammation. In vitro, the compounds improved the cellular aging markers in the cell lines treated with particulate matters or kipopolysacharides. Additionally, it attenuates the lung injury resulting in improving emphysema in animal studies. This study will recruit relatively healthy people with mild subacute respiratory symptoms and it will performed as an 8-week, randomized, double-blind, parallel group, palcebo-controlled study. Intervention arms includes HX 110-A and HX 110- B respectively following 4-week follow-up periods. This study will compare the respiratory symptoms score, total antioxidant capacity, Fractional exhaled nitric oxide (FeNO), and other inflammatory markers among the groups in each visit.

Study Summary Information

Lay Summary

Although respiratory disease is prevalent and may lead to high mortality, it tends to be detected in late status of the disease and the reversibility may be small. As a result, current therapeutic trials in respiratory diseases show small effect in improving respiratory health. It is why the prevention or promoting respiratory health is important to minimizing the risk of respiratory disease.
This study is aimed to improve respiratory health by using compounds of health promotion foods in terms of respiratory symptoms, symptom scores, and attenuation of various inflammatory or oxidant stress. HX 100-A and -B are a kinds of health promotion foods containing Dioscorea polystachya, Adenophora triphylla etc., which are traditionally used to attenuate cough, sputum, and inflammation.
In vitro, the compounds improved the cellular aging markers in the cell lines treated with particulate matters or kipopolysacharides. Additionally, it attenuates the lung injury resulting in improving emphysema in animal studies.
This study will recruit relatively healthy people with mild subacute respiratory symptoms and it will performed as an 8-week, randomized, double-blind, parallel group, palcebo-controlled study. Intervention arms includes HX 110-A and HX 110- B respectively following 4-week follow-up periods.
This study will compare the respiratory symptoms score, total antioxidant capacity, Fractional exhaled nitric oxide (FeNO), and other inflammatory markers among the groups in each visit.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Others (health promotion)
Phase	Phase2/Phase3
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Others (health supplement)
Intervention Description	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 bid control (placebo) lactose mixed powder 500 mg tablet 1tab bid
Number of Arms	3
Arm 1	Arm Label Placebo
	Target Number of Participant 25
	Arm Type Placebo comparator
	Arm Description placebo -subtance: lactose mixed powder -preparation: tablet -weight: 500mg - 1tab bid
Arm 2	Arm Label HX110-A
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description HX110-A -subtance: HX 110-A -preparation: tablet -weight: 500mg (containing HX 110-A 150mg/tab) - 1tab bid 500mg 1tab bid
Arm 3	Arm Label HX110-B
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description HX 110-B -subtance: HX 110-B -preparation: tablet -weight: 500mg (containing HX 110-B 150mg/tab) - 1tab bid 500mg 1tab bid

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (J00-J99)Diseases of the respiratory system (J98.9)Respiratory disorder, unspecified half healthy person with mild respiratory symptoms
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 40Year~No Limit
	Description 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	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
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	total antioxidative capacity
Timepoint	0week, 2week, 4week, 8week, 12week
Primary Outcome(s) 2
Outcome	respiratory symptom scores including BCSS, VAS, CASA-Q, COAT
Timepoint	0week, 2week, 4week, 8week, 12week
Primary Outcome(s) 3
Outcome	inflammatory markers including sRAGE, SP-D, CC-16, CRP, FENO
Timepoint	0week, 2week, 4week, 8week, 12week
Secondary Outcome(s) 1
Outcome	Quality of life (EuroQoL-5D, EQ-5D), Fatiguee symptom score (FSS)
Timepoint	0week, 2week, 4week, 8week, 12week

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

Move list page Move to top