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Acupuncture for Persistent Allergic Rhinitis
ISRCTN ISRCTN90807007
DOI 10.1186/ISRCTN90807007
ClinicalTrials.gov identifier
EudraCT number
Public title Acupuncture for Persistent Allergic Rhinitis
Scientific title Acupuncture for Persistent Allergic Rhinitis: a multicentre randomised sham acupuncture controlled trial
Acronym Acupuncture for PER
Serial number at source KW0901
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.
Lay summary Not provided at time of registration
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
Countries of recruitment China, Korea, South
Disease/condition/study domain Persistent allergic rhinitis
Participants - 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
Participants - 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.
Anticipated start date 01/03/2009
Anticipated end date 30/04/2010
Status of trial Completed
Patient information material
Target number of participants 233 participants, allowing for a 20% withdrawal rate
Interventions 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.

Waitlist:
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).
Primary outcome measure(s) Changes in self-reported nasal symptoms during 7 days after 12 sessions/4 weeks acupuncture treatment and one-month follow-up.
Secondary outcome measure(s) 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
Sources of funding Korea Institute of Oriental Medicine (South Korea) - The Acupuncture, Moxibustion and Meridian Research Project (ref: K09050)
Trial website
Publications 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19602250
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23253122
Contact name Dr  Jong-in  Kim
  Address 483 Exporo Yuseng-gu
  City/town Daejeon
  Zip/Postcode 305-811
  Country Korea, South
  Email han8400@kiom.re.kr
Sponsor Korea Institute of Oriental Medicine (South Korea)
  Address 483 Exporo Yuseng-gu
  City/town Daejeon
  Zip/Postcode 305-811
  Country Korea, South
  Email smchoi@kiom.re.kr
  Sponsor website: http://www.kiom.re.kr
Date applied 11/02/2009
Last edited 02/08/2013
Date ISRCTN assigned 27/02/2009
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