Allergic RhinitisNCT02033252
Acupuncture for Rhinitis Complicated With Asthma
A study testing Acupuncture in people with Allergic Rhinitis and Asthma, run by Jun-Yong Choi at 1 site in South Korea.
Trial summary
This randomized controlled study aimed to evaluate the efficacy and safety of acupuncture therapy on persistent allergic rhinitis patients complicated with asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis, Asthma
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- No problem with expression of opinion
- Provided with written consent
- No other disease except allergic rhinitis or asthma which could affect the disease.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Clinical Research Center, Korean Medicine Hospital, Pusan National University
Yangsan, Kyungsangnamdo, 626-770
Dong Jin Kim, BcS, 82553605902, djkim085@gmail.com
Jun Yong Choi, PhD
About this study
Official title: Acupuncture for Persistent Allergic Rhinitis Complicated With Asthma, A Randomized Controlled Pilot Trial
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
- Being tested
- Acupuncture
- Medical subject headings
- Rhinitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | A series of acupuncture sessions within four weeks from the baseline with concurrent conventional medications for asthma Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
Measured: Change from Baseline TNSS Score at 4 Weeks after Randomization
Secondary outcomes (6)
Rhinitis Quality of Life Questionnaire (RQLQ)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline, four weeks after randomization (both groups)
Euro Quality of Life-5 Dimention Questionnaire (EQ-5D)
Measured: Baseline, four weeks after randomization
Total Nasal Symptom Score (TNSS)
Measured: Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun-Yong Choi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun-Yong Choi, Korean Medicine Hospital of Pusan National University
- Investigators
- Jun-Yong Choi, KMD, PhD, Principal investigator, Korean Medicine Hospital, Pusan National UniversityYun Seong Kim, MD, PhD, Principal investigator, Yangsan Pusan National University HospitalSeung Eun Lee, MD, Study director, Yangsan Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033252
- Sponsor's protocol ID
- NCRC-KIM-02
- Status last verified
- Aug 2015
- First submitted
- 7 Jan 2014
- Last updated
- 2 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Persistent Allergic Rhinitis Complicated With Asthma, A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT02033252
- Acronym / sponsor ID
- NCRC-KIM-02
- Conditions
- Allergic Rhinitis, Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jun-Yong ChoiUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled study aimed to evaluate the efficacy and safety of acupuncture therapy on persistent allergic rhinitis patients complicated with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureA series of acupuncture sessions within four weeks from the baseline with concurrent conventional medications for asthma |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureIn 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. | Device | Acupuncture |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: Change from Baseline TNSS Score at 4 Weeks after Randomization
6 secondary outcomes
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)
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)
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)
Pulmonary function test (PFT)
Time frame: Baseline, four weeks after randomization (both groups)
Euro Quality of Life-5 Dimention Questionnaire (EQ-5D)
Time frame: Baseline, four weeks after randomization
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun-Yong Choi, KMD, PhD principal investigator
Korean Medicine Hospital, Pusan National University
Yun Seong Kim, MD, PhD principal investigator
Yangsan Pusan National University Hospital
Seung Eun Lee, MD study director
Yangsan Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Allergic Rhinitis and Asthma, run by Jun-Yong Choi at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minjoo Kang, BcS (82553605907, syblkmj@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Nasal Symptom Score (TNSS) (time frame: Change from Baseline TNSS Score at 4 Weeks after Randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.