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Effects and Safety of Intranasal Phototherapy for Allergic Rhinitis

Effects and Safety of Intranasal Phototherapy for Allergic Rhinitis: Study Protocol for a Single-center, Randomized, Double-blind, Parallel, Placebo-controlled, Investigator-initiated, Pilot Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003253
Enrollment
40
Registered
2018-10-11
Start date
2018-08-13
Completion date
Unknown
Last updated
2020-06-15

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 : 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 pho

Sponsors

Woosuk University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

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.) ? anti-histamine/H1 blockers within the last 7days ? corticosteroids(intranasal) within the last 14days ? corticosteroids(systemic) within the last 30days ? anti-cholinergic drug within the last 7days ? anti-leukotriene drug within the last 4weeks ? decongestants within the last 3days ? tricyclic antidepressants, phenothiazines within the last 14days ? non-steroidal analgesics within the last 14days ? 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

Design outcomes

Primary

MeasureTime frame
TNSS(Total Nasal Symptom Score)

Secondary

MeasureTime frame
RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire);Serum ImmunoglobulinE, Eosinophil count;Nasal endoscopy;Adverse event

Countries

Korea, Republic of

Contacts

Public ContactJeong-in Kang

Woosuk University

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 18, 2026