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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008894
Enrollment
58
Registered
2023-10-27
Start date
2023-10-13
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

None listed

Interventions

Medical Device : 1) Number of study subjects: 58 people in total (29 control group, 29 test group) 2) Applicable device: Bye-Vi 3) Interventional treatment: Investigation and application to the nasal

Sponsors

Nanobioimaging
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
total symptom score

Secondary

MeasureTime frame
complete blood cell count with difference count;C-reactive protein, CRP;virus Polymerase Chain Reaction Test

Countries

Korea, Republic of

Contacts

Public ContactSEUNG-ROK KANG

Jeonbuk National University Hospital

srkang@mdctc.or.kr+82-63-259-3458

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026