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Acupuncture for Rhinitis Complicated With Asthma

Primary Purpose

Allergic Rhinitis, Asthma

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Acupuncture

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture

Waiting

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Total Nasal Symptom Score (TNSS)

Secondary Outcome Measures

Rhinitis Quality of Life Questionnaire (RQLQ)

Quality of Life Questionnaire for adult Korean Asthmatics (QLQAKA)

Visual Analogue Scale

Pulmonary function test (PFT)

Euro Quality of Life-5 Dimention Questionnaire (EQ-5D)

Total Nasal Symptom Score (TNSS)

Full Information

NCT ID

NCT02033252

First Posted

January 7, 2014

Last Updated

August 31, 2015

Sponsor

Jun-Yong Choi

1. Study Identification

Unique Protocol Identification Number

NCT02033252

Brief Title

Acupuncture for Rhinitis Complicated With Asthma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jun-Yong Choi

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis, Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

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

Arm Title

Waiting

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

Acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Total Nasal Symptom Score (TNSS)

Time Frame

Change from Baseline TNSS Score at 4 Weeks after Randomization

Secondary Outcome Measure Information:

Title

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)

Title

Quality of Life Questionnaire for adult Korean Asthmatics (QLQAKA)

Time Frame

Title

Visual Analogue Scale

Time Frame

Title

Pulmonary function test (PFT)

Time Frame

Baseline, four weeks after randomization (both groups)

Title

Euro Quality of Life-5 Dimention Questionnaire (EQ-5D)

Time Frame

Baseline, four weeks after randomization

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Minjoo Kang, BcS

Phone

82553605907

syblkmj@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun-Yong Choi, KMD, PhD

Organizational Affiliation

Korean Medicine Hospital, Pusan National University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yun Seong Kim, MD, PhD

Organizational Affiliation

Yangsan Pusan National University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Seung Eun Lee, MD

Organizational Affiliation

Yangsan Pusan National University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Yangsan

State/Province

Kyungsangnamdo

ZIP/Postal Code

626-770

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dong Jin Kim, BcS

Phone

82553605902

djkim085@gmail.com

First Name & Middle Initial & Last Name & Degree

Jun Yong Choi, PhD

12. IPD Sharing Statement

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Acupuncture for Rhinitis Complicated With Asthma

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