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Clinical Trials/NCT02033252
NCT02033252
Unknown
Not Applicable

Acupuncture for Persistent Allergic Rhinitis Complicated With Asthma, A Randomized Controlled Pilot Trial

Jun-Yong Choi1 site in 1 country30 target enrollmentStarted: January 2014Last updated:
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ConditionsAllergic RhinitisAsthma

Overview

Phase
Not Applicable
Sponsor
Jun-Yong Choi
Enrollment
30
Locations
1
Primary Endpoint
Total Nasal Symptom Score (TNSS)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This randomized controlled study aimed to evaluate the efficacy and safety of acupuncture therapy on persistent allergic rhinitis patients complicated with asthma.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Outcomes

Primary Outcomes

Total Nasal Symptom Score (TNSS)

Time Frame: Change from Baseline TNSS Score at 4 Weeks after Randomization

Secondary Outcomes

  • Rhinitis Quality of Life Questionnaire (RQLQ)(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))
  • Quality of Life Questionnaire for adult Korean Asthmatics (QLQAKA)(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))
  • Visual Analogue Scale(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))
  • Pulmonary function test (PFT)(Baseline, four weeks after randomization (both groups))
  • Euro Quality of Life-5 Dimention Questionnaire (EQ-5D)(Baseline, four weeks after randomization)
  • Total Nasal Symptom Score (TNSS)(Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only))

Investigators

Sponsor
Jun-Yong Choi
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jun-Yong Choi

Assistant Professor

Korean Medicine Hospital of Pusan National University

Study Sites (1)

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