A multicenter, randomized, parallel design, double-blind, superiority test, prospective clinical trial to confirm the safety and effectiveness of symptom improvement when applying low-output light irradiation device (Bye-Vi) to cold patients.
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0008894
- Lead Sponsor
- anobioimaging
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 58
1. Adult men and women between the ages of 19 and 65
2. Patients whose cold symptoms occurred within 48 hours before clinical trial screening
3. Among the 8 cold symptoms*, those who have a total score of 8 or more for the 4 commonly experienced local symptoms: sore throat, cough, sneezing, and runny nose.
4. A person who agrees not to take any medicine related to colds while participating in a clinical trial
5. Those who fully understand the research purpose and procedures and wish to participate in clinical research through voluntary consent
* The Jackson Symptom score, developed by Jackson in 1958 and widely used in cold clinical trials, is an indicator of five local symptoms: sore throat, runny nose, stuffy nose, cough, and sneezing, and systemic symptoms such as headache, muscle pain, and chills. For each of the three symptoms, 0=no symptoms, 1=mild (feeling it but not difficult or irritating), 2=moderate (somewhat difficult and irritating), 3-severe (difficult and irritating all the time). Calculated by calculating (1, 18).
1. People with known photosensitivity or photoallergy
2. Those with a body temperature of 37.5 degrees or higher
3. Those currently suffering from allergic rhinitis, chronic obstructive pulmonary disease (COPD), or severe nasal syndrome.
4. Those with nasal congestion caused by nasal polyps, previous nasal surgery, or symptoms that may affect the score
5. Those with a history of alcoholism, drug abuse, or use of prescription drugs/unsuitable drugs (e.g. birth control pills, systemic steroids, intranasal drugs, antibiotics, etc.)
6. Persons with symptoms of infection other than respiratory tract
7. Pregnant and lactating women, those who test positive for pregnancy on a urine test, and those who are planning to become pregnant during the clinical trial period.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method total symptom score
- Secondary Outcome Measures
Name Time Method complete blood cell count with difference count;C-reactive protein, CRP;virus Polymerase Chain Reaction Test