- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01295255
Interaction Effect of Asthma and Aeroallergen Category on the Psychological Status in Allergic Rhinitis Patients
11. februar 2011 opdateret af: Beijing Tongren Hospital
Allergic rhinitis (AR) and asthma are considered as "one airway, one disease".
Although there is increasing evidence for an association between allergy and depression, it remains unknown if the relationship between AR and asthma has extra influence on the psychological status of the patients.
The aim of our study was to investigate the influence pattern of asthma on the psychological status in AR patients.
The Symptom Checklist-90 (SCL-90) was employed to analyze the psychological status of 524 individuals with AR.
Independent sample T-tests, one-way ANOVA and multivariate ANOVA were used for data analyses.
Studieoversigt
Status
Afsluttet
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
524
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 60 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
524 affected individuals (311 males and 213 females) with AR were prospectively recruited from the rhinology clinic of the Otolaryngology, Head and Neck Surgery Department of Beijing Tongren Hospital from February 2009 to November 2009.
Beskrivelse
Inclusion Criteria:
- Patients suffered from rhinitis symptoms such as nasal itching, sneezing, nasal obstruction and running nose, all patients had not undergone any medicine therapy in the past one week; nasal endoscopy showed a pale and edematous nasal mucosa, nasal discharge and swollen inferior turbinates. Every nasal symptom was scored on Visual analog scale (VAS, 0-3 score) respectively. A score of 0 indicated no nasal symptom, 1 indicated slight nasal symptoms, 2 indicated obvious nasal symptom, but which could still be endured, and 3 indicated obvious nasal symptoms that could not be endured;
- Age between 16 to 60 years;
- A positive skin prick test (SPT)to at least one allergen, the level of response equal to or exceeding ++. The following inhalant allergens were tested: Der p; Der f; Animal hair; Trees; Grasses; Cereals; Mugwort; Dandelion; Giant ragweed; Chenopodium album; Humulus; Locust; Blatella germanica; Pine; Plantain; Curvularia lunata; Candida albicans; Penicillium notatum; Alternaria tenuis and Aspergillus fumigatu. The reactions were evaluated based on the mean wheal diameter at 15 minutes after application of the extracts. The mean diameters of each allergen wheals were calculated from the sum of the largest measurement across the wheal and the largest wheal measurement perpendicular to this divided by two. In addition, we calculated the skin index (SI) as the ratio of allergen weal diameter divided by the histamine weal size. The SPT result for each allergen was defined in terms of the SI value as follows: +: SI≤0.5; ++: 0.5<SI≤1.0; +++: 1.0<SI≤2.0; ++++: SI>2.0.
Exclusion Criteria:
- AR combined with hypertension, diabetes or other chronic diseases;
- AR combined with tumor in the nasal cavity;
- AR combined with eczema;
- Acute infection in the past one week;
- Failure to complete the questionnaires;
- AR patients undergoing negative life events.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: DeMin Han, Phd, Beijing Tongren Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2009
Primær færdiggørelse (Faktiske)
1. oktober 2009
Studieafslutning (Faktiske)
1. november 2009
Datoer for studieregistrering
Først indsendt
11. februar 2011
Først indsendt, der opfyldte QC-kriterier
11. februar 2011
Først opslået (Skøn)
14. februar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. februar 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. februar 2011
Sidst verificeret
1. januar 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1130
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