Acupuncture for Rhinitis Complicated With Asthma

NCT ID: NCT02033252

Last Updated: 2015-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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

Detailed Description

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Conditions

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Allergic Rhinitis Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture

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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type 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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jun-Yong Choi

OTHER

Sponsor Role lead

Responsible Party

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Jun-Yong Choi

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jun-Yong Choi, KMD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korean Medicine Hospital, Pusan National University

Yun Seong Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yangsan Pusan National University Hospital

Seung Eun Lee, MD

Role: STUDY_DIRECTOR

Yangsan Pusan National University Hospital

Locations

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

Yangsan, Kyungsangnamdo, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Minjoo Kang, BcS

Role: CONTACT

82553605907

Facility Contacts

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Dong Jin Kim, BcS

Role: primary

82553605902

Other Identifiers

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NCRC-KIM-02

Identifier Type: -

Identifier Source: org_study_id

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