Acupuncture for Rhinitis Complicated With Asthma

NCT02033252 | Unknown

• 1 other identifier: NCRC-KIM-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Rhinitis; Asthma

Outcome Measures

Primary Outcomes (1)

• Total Nasal Symptom Score (TNSS)

  Change from Baseline TNSS Score at 4 Weeks after Randomization

Secondary Outcomes (6)

• 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

Study Arms (2)

Acupuncture

EXPERIMENTAL

A series of acupuncture sessions within four weeks from the baseline with concurrent conventional medications for asthma

Device: Acupuncture

Waiting

NO INTERVENTION

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).

Interventions

Acupuncture DEVICE

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.

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jun-Yong Choi: lead

Study Sites (1)

National Clinical Research Center, Korean Medicine Hospital, Pusan National University

Yangsan, Kyungsangnamdo, 626-770, South Korea

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jun-Yong Choi, KMD, PhD

  Korean Medicine Hospital, Pusan National University

  PRINCIPAL INVESTIGATOR

• Yun Seong Kim, MD, PhD

  Yangsan Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

• Seung Eun Lee, MD

  Yangsan Pusan National University Hospital

  STUDY DIRECTOR

Central Study Contacts

Minjoo Kang, BcS

CONTACT

82553605907; syblkmj@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 10, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

KR (1)