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Acupuncture for Rhinitis Complicated With Asthma

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ClinicalTrials.gov Identifier: NCT02033252
Recruitment Status : Unknown
Verified August 2015 by Jun-Yong Choi, Korean Medicine Hospital of Pusan National University.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Jun-Yong Choi, Korean Medicine Hospital of Pusan National University

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

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Asthma Device: Acupuncture Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Persistent Allergic Rhinitis Complicated With Asthma, A Randomized Controlled Pilot Trial
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Acupuncture
A series of acupuncture sessions within four weeks from the baseline with concurrent conventional medications for asthma
 Device: Acupuncture
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.
No Intervention: 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).


Outcome Measures
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Primary Outcome Measures :
  1. Total Nasal Symptom Score (TNSS) [ Time Frame: Change from Baseline TNSS Score at 4 Weeks after Randomization ]

Secondary Outcome Measures :
  1. Rhinitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 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) ]
  2. Quality of Life Questionnaire for adult Korean Asthmatics (QLQAKA) [ Time Frame: 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) ]
  3. Visual Analogue Scale [ Time Frame: 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) ]
  4. Pulmonary function test (PFT) [ Time Frame: Baseline, four weeks after randomization (both groups) ]
  5. Euro Quality of Life-5 Dimention Questionnaire (EQ-5D) [ Time Frame: Baseline, four weeks after randomization ]
  6. Total Nasal Symptom Score (TNSS) [ Time Frame: Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Moderate-severe symptoms according to Allergic rhinitis and its impact on asthma (ARIA) criteria.
  3. Positive reaction for more than or equal to one respiratory allergen (SPT or MAST)
  4. Stable asthma symptoms with diagnosis of Asthma by respiratory or allergic disease specialist.
  5. No changes in asthma or allergic rhinitis drugs for the past month
  6. Aged greater than or equal to 18 years, either sex.
  7. No problem with expression of opinion
  8. Provided with written consent
  9. No other disease except allergic rhinitis or asthma which could affect the disease.

Exclusion Criteria:

  1. Having experience using ventilator due to exacerbation of asthma symptoms within six months.
  2. Experience of acute respiratory tract infection treated with antibiotics within 14 days
  3. Having anatomical occlusion or deformation in nasal cavity.
  4. Signs of infection in chest X-ray or having active respiratory disease except asthma
  5. Below or equal to 4 on Total nasal symptom score (TNSS) in the latest week.
  6. Received drugs affecting directly to allergic rhinitis such as H1-antihistamines, decongestants (nasal, oral or ocular), corticosteroids within 14 days.
  7. 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.
  8. Received herbal medication for allergic rhinitis or asthma within 14 days.
  9. Pregnant, planning the pregnancy or breast-feeding
  10. Tuberculosis, hepatitis or more than 2 x normal limit of serum creatinine, aspartate aminotransferase/alanine aminotransferase (AST/ALT).
  11. Skin lesion on acupoint or other systemic disease insufficient for acupuncture.
  12. Night-shift workers staying up all night
  13. Who cannot participate clinical trial properly.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033252


Contacts
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Contact: Minjoo Kang, BcS 82553605907 syblkmj@hanmail.net

Locations
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Korea, Republic of
National Clinical Research Center, Korean Medicine Hospital, Pusan National University Recruiting
Yangsan, Kyungsangnamdo, Korea, Republic of, 626-770
Contact: Dong Jin Kim, BcS    82553605902    djkim085@gmail.com   
Principal Investigator: Jun Yong Choi, PhD         
Sponsors and Collaborators
Jun-Yong Choi
Investigators
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Principal Investigator: Jun-Yong Choi, KMD, PhD Korean Medicine Hospital, Pusan National University
Principal Investigator: Yun Seong Kim, MD, PhD Yangsan Pusan National University Hospital
Study Director: Seung Eun Lee, MD Yangsan Pusan National University Hospital
More Information
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Responsible Party: Jun-Yong Choi, Assistant Professor, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier: NCT02033252     History of Changes
Other Study ID Numbers: NCRC-KIM-02
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Asthma
Rhinitis
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases