The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis
9. november 2017 oppdatert av: Eun Jung Kim
The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis: a Randomized, Open-label, Assessment-blind, Parallel Designed Pilot Clinical Study
The purpose of this study is verify the efficacy and safety of Cettum (Electrical moxibustion) for patients with perennial allergic rhinitis.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The investigators target the patients with perennial allergic rhinitis.
After treatment in 2 groups (Cettum treatment and acupuncture treatment) the investigators will compare the effects of relieving symptoms and improving quality of life.
So the investigators will confirm the efficacy of Cettum, and further the best treatment method.
In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.
Studietype
Intervensjonell
Registrering (Forventet)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 19 to 60 years-old
- Presence of nasal symptoms more than 2 consecutive years
- Presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) with severity score ≥ 2 (0 = no symptoms, 1 = mild symptom(s), 2 = moderate symptom(s), and 3 = severe symptom(s))
- Positive reaction to the one or more perennial allergen in skin prick test
- Not having a problem with expression of opinion
- Willingness to participate in this trial and to sign the informed consent agreement
Exclusion Criteria:
- Treatment with nasal/oral corticosteroids within the past month; herbal medication for rhinitis within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week
- Presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening or opacification of the paranasal sinuses)
- Presence of neoplasm, severe systemic inflammation, or other systemic disease that affects rhinitis
- History of anaphylaxis for allergic tests
- Females who is pregnant or lactating
- Being difficult to maintain treatment (e.g. paralysis, severe physical or psychiatric disorder, dementia, drug intoxication, severe visual or hearing impairment)
- Being afraid of moxibustion treatment or expected adverse effects
- When the investigators determine that it is inappropriate for participation
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Cettum (Electrical moxibustion)
The patients in this group will receive Cettum (Electrical moxibustion) treatment applied by a certified Korean Medicine Doctor with more than 6 years of traditional Korean medicine college education.
|
The treatment will be applied in 8 sessions, 2 times per week for 4 weeks.
Moxibustion will be provided at 11 standard acupuncture points: EX-HN3, and both EX-HN8, LI20, LI4, GB2, ST36.
A specifically designed device, Cettum (20X28X18mm) manufactured by K-medical Co.(Korea), will be used to treat patients in this group.
The expected total time of each treatment session will be 15 min.
Andre navn:
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Aktiv komparator: Acupuncture
The patients in this group will receive acupuncture treatment applied by a certified Korean Medicine Doctor with more than 6 years of traditional Korean medicine college education.
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The treatment will be applied in 8 sessions, 2 times per week for 4 weeks.
Acupuncture will be provided at same points in the Cettum group.
Sterile stainless steel disposable acupuncture needles (0.25X30mm, DongBang Acupuncture Inc, Korea) will be used to treat patients in this group.
The needles will be kept in place for 15 min.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Total Nasal Symptom Score (TNSS)
Tidsramme: 4 weeks
|
TNSS evaluates symptoms of rhinorrhea, nasal congestion, nasal itching and sneezing on a 4-point scale.
The total score range is from 0 to 12, where 0 = no symptoms, 1 = mild symptom(s), 2 = moderate symptom (s), and 3 = severe symptom(s).
TNSS baseline value will be measured prior to the start of the experiment and then again during every visit.
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4 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rhinoconjunctivits Quality of Life Questionnaire (RQLQ)
Tidsramme: 4 weeks
|
RQLQ is self-report questionnaire used to assess the quality of life in patients with allergic rhinitis.
The questionnaire has 7 domains; activity limitations, sleep disturbances, non-hay fever symptoms, practical problems, nasal symptoms, ocular symptoms and emotional problems.
Patients will be asked to recall their experiences during the previous week and to rate each question on a ranging from 0 (no impairment) to 6 (severe impairment).
RQLQ will be measured during visits 2, 6, 9, and 10.
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4 weeks
|
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Total serum IgE and eosinophil count levels
Tidsramme: 4 weeks
|
Total serum IgE and eosinophil count levels will be measured during visits 2 and 9.
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4 weeks
|
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Pre KiFDA AR version 2.0
Tidsramme: 4 weeks
|
The investigator, traditional Korean medicine doctor, will evaluate the nasal endoscopy index during visits 2 and 9.
The investigator will check the score following observation of the nasal membrane color, rhinorrhea, and inferior turbinate swelling of the patient via nasal endoscopy.
|
4 weeks
|
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Pre KiFDA AR version 3.0
Tidsramme: 4 weeks
|
The investigator, traditional Korean medicine doctor, will select a pattern for each patient from among lung-heat, lung-cold and spleen-qi-deficiency through face-to-face diagnoses, based on body and nasal conditions.
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4 weeks
|
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Adverse Events
Tidsramme: 4 weeks
|
Any unpredicted symptoms are checked at every visit and if any, the symptom, time of occurrence, and length of duration are recorded and reported.
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4 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Seung Ug Hong, Ph. D., Dongguk University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Jo HR, Sung WS, Jung CY, Lim CY, Lee SD, Hong SU, Kim KH, Kim EJ. Effectiveness and safety of electric heating moxibustion for perennial allergic rhinitis: A pilot, randomized, assessor-blind trial. Complement Ther Med. 2022 Sep;68:102835. doi: 10.1016/j.ctim.2022.102835. Epub 2022 Apr 22.
- Jung CY, Cho MJ, Kang HR, Hong SU, Sung WS, Kim EJ. Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial. Trials. 2019 Jul 19;20(1):445. doi: 10.1186/s13063-019-3550-x.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. desember 2017
Primær fullføring (Forventet)
1. desember 2018
Studiet fullført (Forventet)
1. desember 2018
Datoer for studieregistrering
Først innsendt
9. november 2017
Først innsendt som oppfylte QC-kriteriene
9. november 2017
Først lagt ut (Faktiske)
14. november 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. november 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. november 2017
Sist bekreftet
1. november 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DUIH 2017-0013
Plan for individuelle deltakerdata (IPD)
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