Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Jong-in Kim


Contact details

483 Exporo Yuseng-gu

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Acupuncture for Persistent Allergic Rhinitis: a multicentre randomised sham acupuncture controlled trial


Acupuncture for PER

Study hypothesis

The primary objective of the present protocol is to investigate the effectiveness of acupuncture in patients with moderate-severe persistent allergic rhinitis (PER) in Korea and China, compared to sham acupuncture and a no-acupuncture waitlist status.

Ethics approval

1. Kyung-Hee University Medical Center Ethics Committee gave approval on the 11th February 2009
2. Daegeon Oriental Hospital Ethics Committee gave approval on the 23rd January 2009

Study design

Multicentre randomised, subject and assessor blinded, sham acupuncture and waitlist controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Persistent allergic rhinitis


The study includes the following periods in all groups: a run-in period of 1 week before randomisation, a treatment (acupuncture or sham) period of 4 weeks (3 sessions/week), and a follow-up period of 4 weeks.

Acupuncture group:
In the acupuncture treatment group, 10 acupuncture points (bilateral LI4, LI20, ST2 and ST36, unilateral EX-1 and GV23) 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 time manual stimulations, starting and ending point.

Sham acupuncture group:
The insertion sites will be 1 - 1.5 cm from the acupuncture points used for active acupuncture treatment and will be penetrated with the same type of acupuncture needles; the needle will be inserted to a depth of 3 - 5 mm with a perpendicular direction using hollow pool in a shallow needling technique to avoid de-qi. The needle is then rotated one time in order to preserve patient blinding.

Participants who will be allocated to waitlist will receive no acupuncture or sham acupuncture treatments throughout the 4 weeks. After 4 weeks, if participants elect to try the acupuncture treatment, the active acupuncture treatment will be provided, acupuncture treatment period of 4 weeks (3 sessions/week).

Intervention type



Not Applicable

Drug names

Primary outcome measure

Changes in self-reported nasal symptoms during 7 days after 12 sessions/4 weeks acupuncture treatment and one-month follow-up.

Secondary outcome measures

Measured after 12 sessions/4 weeks acupuncture treatment:
1. Rhinitis Quality of Life Questionnaire (RQLQ) score
2. Total non-nasal symptom score (i.e. headache, itching, pain, eye dropping)

Measured during follow-up period:
3. Quantity of conventional relief medication use

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Diagnosis of PER, with moderate-severe or severe degree, according to the criteria of Allergic Rhinitis and its Impact on Asthma (ARIA) initiative
2. Completed baseline AR diary and provided written informed consent
3. Aged greater than or equal to 18 years of age, either sex
4. Recruited from each centre by the use of local newspaper advertisements and posted notices at each site
5. Have had PER for greater than 4 days/week, and greater than 4 consecutive weeks

Participant type


Age group




Target number of participants

233 participants, allowing for a 20% withdrawal rate

Participant exclusion criteria

1. Suffering serious medical conditions such as uncontrolled hypertension, diabetes mellitus requiring insulin injection, past or current malignant tumour, severe dyslipidaemia or liver and kidney dysfunction, anaemia, active pulmonary tuberculosis, other infectious disease or systemic diseases insufficient for acupuncture treatment
2. Congenital nasal abnormalities
3. Sinusitis or active asthma
4. Operation history
5. Received systemically administered corticosteroids within 6 months before enrolment
6. Received alternative and complementary modality, i.e. acupuncture or herbal medication for treating AR within 6 months

Topical oral and nasal H1 blockers, or corticosteroid, or nasal anti-cholinergic medication will be stopped before 1 week before enrolment.

Recruitment start date


Recruitment end date



Countries of recruitment

China, Korea, South

Trial participating centre

483 Exporo Yuseng-gu
Korea, South

Sponsor information


Korea Institute of Oriental Medicine (South Korea)

Sponsor details

483 Exporo Yuseng-gu

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Korea Institute of Oriental Medicine (South Korea) - The Acupuncture, Moxibustion and Meridian Research Project (ref: K09050)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2009 protocol in
2013 results in

Publication citations

  1. Protocol

    Kim JI, Lee MS, Jung SY, Choi JY, Lee S, Ko JM, Zhao H, Zhao J, Kim AR, Shin MS, Kang KW, Jung HJ, Kim TH, Liu B, Choi SM, Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol., Trials, 2009, 10, 54, doi: 10.1186/1745-6215-10-54.

  2. Results

    Choi SM, Park JE, Li SS, Jung H, Zi M, Kim TH, Jung S, Kim A, Shin M, Sul JU, Hong Z, Jiping Z, Lee S, Liyun H, Kang K, Baoyan L, A multicenter, randomized, controlled trial testing the effects of acupuncture on allergic rhinitis., Allergy, 2013, 68, 3, 365-374, doi: 10.1111/all.12053.

Additional files

Editorial Notes