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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, Parallel (acupuncture-controlled), Open-label, Investigator-initiated, Pilot Study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004079
Enrollment
80
Registered
2019-06-20
Start date
2019-06-24
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 : Intervention : Patients receive low-level laser phototherapy in single intranasal cavity, using medical device for 20 minutes, three times per week for 4weeks. Control : Patients rece

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 last 14days 3) Laser therapy to treat allergic rhinitis within the last 14days 4) Patients who have had treatments due to acute upper respiratory infections or sinusitis, within the last 4weeks 5) Non-allergic rhinitis such as vasomotor, infectious, drug-induced rhinitis, or other severe nasal illness 6) Anatomical obstruction or deformities of the nasal cavity or nasal surgery within the past 6 months 7) Malignant neoplasm, anemia, active pulmonary tuberculosis, infection or other severe systemic disease 8) Past history of active respiratory disease like asthma 9) Immunotherapy or systemic corticosteroids therapy within the last 5 years 10) hypersensitivity reaction to phototherapy or taking related drugs 11) scar on the irradiation(or acupuncture) spot 12) Pregnancy, planning a pregnancy or breast-feeding 13) Participation in other clinical trials within the last 1 month 14) Difficulties in enrolling this trial or receiving treatment 15) 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