본문바로가기



  • Status : Approved
    • First Submitted Date : 2018/08/13
    • Registered Date : 2018/10/11
    • Last Updated Date : 2018/10/11
  • 페이스북공유하기
  • 트위터공유하기
  • 구글플러스공유하기
  • 카카오스토리공유하기
  • 네이버밴드공유하기
  • 출력

1. Background

Background Information
CRIS
Registration Number
KCT0003253 
Unique Protocol ID WSOH IRB M1807-01 
Public/Brief Title Effects and Safety of Intranasal Phototherapy for Allergic Rhinitis 
Scientific Title Effects and Safety of Intranasal Phototherapy for Allergic Rhinitis : a Single Center, Randomized, Double-blind, Parallel, Placebo-controlled, Investigator-initiated, Pilot Study.  
Acronym  
MFDS Regulated Study Yes
IND/IDE Protocol No
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 WSOH IRB M1807-01 
Approval Date 2018-07-23 
Institutional Review Board  
Name Institutional Review Board of the Woosuk University Korean Medicine Hospital  
Address 46, Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do 
Telephone 063-220-8627 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Dong-hyo Lee 
Title Assistant professor 
Telephone  
Affiliation Woosuk University 
Address 46, Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do, Republic of Korea 
Contact Person for Public Queries
Name Jeong-in Kang 
Title Resident 
Telephone +82-63-220-8615 
Affiliation Woosuk University 
Address 46, Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do, Republic of Korea 
Contact Person for Updating Information
Name Jeong-in Kang 
Title Resident 
Telephone +82-63-220-8615 
Affiliation Woosuk University 
Address 46, Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do, Republic of Korea 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2018-08-13 , Actual
Target Number of Participant 40
Primary Completion Date
Study Completion Date
Recruitment Status by Participating Study Site 1
Name of Study Site Woosuk University Korean Medicine Medical Center 
Recruitment Status Recruiting  
Date of First Enrollment 2018-08-13 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Ministry of Health & Welfare 
Organization Type Government  
Project ID HB16C0009 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Woosuk University 
Organization Type University  

7. Study Summary

Study Summary Information
Lay Summary To investigate the clinical effects and safety of intranasal phototherapy for the treatment of allergic rhinitis, a randomized, double-blind, parallel, placebo-controlled, investigator-initiated, pilot study has been designed.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Double 
Blinded Subject Subject, Investigator 
Allocation RCT 
Intervention Type Medical Device  
Intervention Description Invention : Patients receive low-level laser phototherapy in each intranasal cavity, using medical device for 20minutes, 5 times a week for 2weeks.
Control : Patients receive sham phototherapy in each intranasal cavity, using sham device for 20minutes, 5 times a week for 2weeks.  
Number of Arms
Arm 1 Arm Label Medica Device(Low-level laser) 
Target Number of Participant 20 
Arm Type Experimental 
Arm Description Patients receive low-level laser phototherapy in each intranasal cavity, using medical device for 20minutes, 5 times a week for 2weeks. 
Arm 2 Arm Label Sham Device 
Target Number of Participant 20 
Arm Type Sham comparator 
Arm Description Patients receive sham phototherapy in each intranasal cavity, using sham device for 20minutes, 5 times a week for 2weeks. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of th respiratory system
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ No Limit
Description Presence of two or more symptoms of allergic rhinitis(nasal congestion, rhinorrhea, nasal itching and sneezing) and Positive reaction to an allergen in multiple allergen simultaneous test  
Exclusion Criteria 1) Patients who take any medication as follows or who can’t stop taking medication which is unsuitable for this clinical trail.(But they can be enrolled in this trial after the minimum Wash-out period as suggested, before Visit2.)
① anti-histamine/H1 blockers within the last 7days
② corticosteroids(intranasal) within the last 14days
③ corticosteroids(systemic) within the last 30days
④ anti-cholinergic drug within the last 7days
⑤ anti-leukotriene drug within the last 4weeks
⑥ decongestants within the last 3days
⑦ tricyclic antidepressants, phenothiazines within the last 14days
⑧ non-steroidal analgesics within the last 14days
⑨ Others (inappropriate medications)
2) Korean Medicine treatment(herbal medicine, acupuncture, moxibustion, cupping, etc) to treat allergic rhinitis within the past 14days
3) Laser therapy to treat allergic rhinitis within the past 14days
4) Malignant neoplasm, anemia, active pulmonary tuberculosis, infection or other severe systemic disease
5) Anatomical obstruction or deformities of the nasal cavity or nasal surgery within the past 6months
6) Past history of active respiratory disease like asthma
7) Hypertension or diabetes
8) Immunotherapy or systemic corticosteroids therapy within the past 2 years
9) hypersensitivity reaction to phototherapy or taking related drugs
10) scar on the irradiation spot
11) Pregnancy, planning a pregnancy or breast-feeding
12) Participation in other clinical trials within the past 1 month
13) Difficulties in enrolling this trial or receiving treatmen
14) Ineligibility for participation as judged by the investigator  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
Outcome TNSS(Total Nasal Symptom Score) 
Timepoint screening, visit2-11 
Secondary Outcome(s) 1 
Outcome RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) 
Timepoint visit2, visit11 
Secondary Outcome(s) 2 
Outcome Serum ImmunoglobulinE, Eosinophil count 
Timepoint screening, visit11 
Secondary Outcome(s) 3 
Outcome Nasal endoscopy 
Timepoint screening, visit2-11 
Secondary Outcome(s) 4 
Outcome Adverse event 
Timepoint visit2-11, Follow up 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

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

Sharing of Study Data Information
Sharing Statement No 
  • 출력
Quick Link
자주하시는 질문
Q&A
등록절차
입력항목설명집