Acupuncture for Rhinitis Complicated With Asthma
31. august 2015 opdateret af: Jun-Yong Choi
Acupuncture for Persistent Allergic Rhinitis Complicated With Asthma, A Randomized Controlled Pilot Trial
This randomized controlled study aimed to evaluate the efficacy and safety of acupuncture therapy on persistent allergic rhinitis patients complicated with asthma.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Kyungsangnamdo
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Yangsan, Kyungsangnamdo, Korea, Republikken, 626-770
- Rekruttering
- National Clinical Research Center, Korean Medicine Hospital, Pusan National University
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Kontakt:
- Dong Jin Kim, BcS
- Telefonnummer: 82553605902
- E-mail: djkim085@gmail.com
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Ledende efterforsker:
- Jun Yong Choi, PhD
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Suffering from persistent Allergic rhinitis (PAR; nasal obstruction, rhinorrhoea, sneezing and nasal itching) symptoms for more than 4 days/week, and greater than 4 consecutive weeks.
- Moderate-severe symptoms according to Allergic rhinitis and its impact on asthma (ARIA) criteria.
- Positive reaction for more than or equal to one respiratory allergen (SPT or MAST)
- Stable asthma symptoms with diagnosis of Asthma by respiratory or allergic disease specialist.
- No changes in asthma or allergic rhinitis drugs for the past month
- Aged greater than or equal to 18 years, either sex.
- No problem with expression of opinion
- Provided with written consent
- No other disease except allergic rhinitis or asthma which could affect the disease.
Exclusion Criteria:
- Having experience using ventilator due to exacerbation of asthma symptoms within six months.
- Experience of acute respiratory tract infection treated with antibiotics within 14 days
- Having anatomical occlusion or deformation in nasal cavity.
- Signs of infection in chest X-ray or having active respiratory disease except asthma
- Below or equal to 4 on Total nasal symptom score (TNSS) in the latest week.
- Received drugs affecting directly to allergic rhinitis such as H1-antihistamines, decongestants (nasal, oral or ocular), corticosteroids within 14 days.
- Received following treatments for allergic rhinitis or asthma within six months ; Traditional Korean medicine interventions such as acupuncture, moxibustion, cupping therapy and herbal medication inhalation or CAM including homeopathy.
- Received herbal medication for allergic rhinitis or asthma within 14 days.
- Pregnant, planning the pregnancy or breast-feeding
- Tuberculosis, hepatitis or more than 2 x normal limit of serum creatinine, aspartate aminotransferase/alanine aminotransferase (AST/ALT).
- Skin lesion on acupoint or other systemic disease insufficient for acupuncture.
- Night-shift workers staying up all night
- Who cannot participate clinical trial properly.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Acupuncture
A series of acupuncture sessions within four weeks from the baseline with concurrent conventional medications for asthma
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In the acupuncture treatment group, 10 acupuncture points (bilateral LI4, TE23, ST36, unilateral EHN-1, GV23, LI20 and LI4) will be inserted with 0.20 mm in diameter x 30 mm in length disposal needles.
The needle will be inserted to a depth of 10 - 30 mm, according to the points selected.
The participating acupuncture doctors will manually manipulate the acupuncture needles with de-qi sensation and maintain the needles for 10 minutes with two times of manual stimulation, at the beginning and at the end.
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Ingen indgriben: Waiting
Participants who will be allocated to waitlist will receive no acupuncture treatments throughout the 4 weeks while receiving other conventional managements for asthma.
After 4 weeks, if participants choose to try the acupuncture treatment, the active acupuncture treatment will be provided for 4 weeks (3 sessions/week).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Total Nasal Symptom Score (TNSS)
Tidsramme: Change from Baseline TNSS Score at 4 Weeks after Randomization
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Change from Baseline TNSS Score at 4 Weeks after Randomization
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Rhinitis Quality of Life Questionnaire (RQLQ)
Tidsramme: Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
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Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
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Quality of Life Questionnaire for adult Korean Asthmatics (QLQAKA)
Tidsramme: Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
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Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
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Visual Analogue Scale
Tidsramme: Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
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Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
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Pulmonary function test (PFT)
Tidsramme: Baseline, four weeks after randomization (both groups)
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Baseline, four weeks after randomization (both groups)
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Euro Quality of Life-5 Dimention Questionnaire (EQ-5D)
Tidsramme: Baseline, four weeks after randomization
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Baseline, four weeks after randomization
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Total Nasal Symptom Score (TNSS)
Tidsramme: Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
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Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jun-Yong Choi, KMD, PhD, Korean Medicine Hospital, Pusan National University
- Ledende efterforsker: Yun Seong Kim, MD, PhD, Yangsan Pusan National University Hospital
- Studieleder: Seung Eun Lee, MD, Yangsan Pusan National University 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. januar 2014
Primær færdiggørelse (Forventet)
1. december 2015
Datoer for studieregistrering
Først indsendt
7. januar 2014
Først indsendt, der opfyldte QC-kriterier
9. januar 2014
Først opslået (Skøn)
10. januar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. september 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2015
Sidst verificeret
1. august 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NCRC-KIM-02
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .