Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000751279
Ethics application status
Approved
Date submitted
28/08/2009
Date registered
28/08/2009
Date last updated
16/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial on acupuncture for hay fever
Scientific title
The efficacy and safety of acupuncture for seasonal allergic rhinitis: a prospective, randomised controlled trial
Secondary ID [1] 288174 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AcupSAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seasonal Allergic Rhinitis (SAR) 4762 0
Condition category
Condition code
Inflammatory and Immune System 237100 237100 0 0
Allergies
Respiratory 237101 237101 0 0
Other respiratory disorders / diseases
Alternative and Complementary Medicine 237102 237102 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After a two-week run-in period, the subjects will be treated three times per week for four weeks. Four key (common) acupoints and two supplementary acupoints will be used. “Hwato” disposable pre-sterilised needles will be used. The needle will be 0.22 mm in diameter. The length of the needle will depend on the acupoint locations (25 – 50 mm). The duration of each acupuncture session is 25 minutes.
Intervention code [1] 4538 0
Treatment: Devices
Comparator / control treatment
Sham acupuncture will be used as the control treatment, needles will be inserted shallowly, 1.5 cm lateral to the selected acupoints. The subjects will be treated three times per week for four weeks. The duration of each acupuncture session is 25 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 5932 0
Self-assessed nasal (sneezing, watery rhinorrhoea, nasal congestion and nasal itching) and non-nasal (ocular itching, watering, and redness, and itching of the ears and/or palate) symptom scores. Subjects will record these symptoms in a diary daily as well as assessing the overall severity weekly.
Timepoint [1] 5932 0
Weeks 1, 2,3, 4
Secondary outcome [1] 242025 0
Rhinoconjunctivitis quality of life questionnaire (RQLQ) that consists of seven domains: sleep, practical problems; non-nasal/eye symptoms; nasal symptoms; eye symptoms; activities; and, emotional function.
Timepoint [1] 242025 0
Weeks, 1, 2,3, 4
Secondary outcome [2] 242026 0
Relief medication score (RMS)
Timepoint [2] 242026 0
Weeks, 1, 2,3, 4
Secondary outcome [3] 242027 0
Adverse event record. An adverse event record form will be provided for all subjects to record any unexpected signs, symptoms, and feelings during and after the treatment period. Details of any adverse events will be scored using a six-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = extremely severe) to indicate the severity of these events.
Timepoint [3] 242027 0
Weeks 1, 2,3, 4

Eligibility
Key inclusion criteria
Age between 18 and 70 inclusive; a history of at least two years of typical symptoms of SAR, or of persistent allergic rhinitis (PAR) with seasonal exacerbation, including watery rhinorrhoea, sneezing, nasal obstruction and nasal and ocular itch. Although it is common for SAR sufferers to be also sensitised to allergens such as house dust mites, seasonal worsening of symptoms markedly increases morbidity and it is considered unlikely that such worsening of symptoms during the period of high grass pollen counts would be due to PAR rather than to SAR. However, a positive skin-prick test to rye grass pollen will be required for all participants.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of Human immunodeficiency virus(HIV); current pregnancy or breast-feeding; other current active respiratory diseases such as asthma, sinusitis, and rhinitis medicamentosa; pollen desensitization during the last 6 months; nasal polyposis; other structural defects of the upper respiratory tract; hepatitis B or C; and, currently use systemic corticosteroid therapy or anticoagulant medications. Respondents with atopic dermatitis and who are regularly using topical corticosteroids will also be excluded. In addition, subjects who have experienced acupuncture within the last 24 months will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation codes will be put into sequentially numbered, opaque, sealed envelopes. The code will only be revealed to the acupuncturist immediately before the first treatment, after the subjects picked one envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2009
Actual
12/10/2009
Date of last participant enrolment
Anticipated
Actual
20/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
138
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4949 0
Government body
Name [1] 4949 0
NHMRC
Country [1] 4949 0
Australia
Primary sponsor type
Individual
Name
Prof. Charlie Xue
Address
World Health Organisation (WHO) Collaborating Center for Traditional Medicine, Royal Melbourne Institute of Technology (RMIT) University, PO Box 71, Bundoora, VIC 3083
Country
Australia
Secondary sponsor category [1] 4468 0
None
Name [1] 4468 0
Address [1] 4468 0
Country [1] 4468 0
Other collaborator category [1] 669 0
Individual
Name [1] 669 0
A/Prof. Frank Thien
Address [1] 669 0
Dept of Respiratory Medicine, Eastern Health. Box Hill Hospital. Nelson Road, Box Hill, VIC 3128.
Country [1] 669 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7047 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 7047 0
Research and Innovation, GPO Box 2476V, Melbourne, VIC 3001
Ethics committee country [1] 7047 0
Australia
Date submitted for ethics approval [1] 7047 0
Approval date [1] 7047 0
01/05/2009
Ethics approval number [1] 7047 0
5/09/2009

Summary
Brief summary
Seasonal allergic rhinitis, also known as hay fever, is a common condition with high prevalence in Australia, being most pronounced during spring and early summer when pollen counts are highest. There is no proven cure for hay fever. Many hay fever sufferers seek alternative therapies such as acupuncture. We propose to undertake a rigorous study, using well-established clinical trial methodology, to evaluate the efficacy and safety of acupuncture in the treatment of hay fever.
Trial website
www.rmit.edu.au/chinese-med
Trial related presentations / publications
Ann Allergy Asthma Immunol. 2015 Oct;115(4):317-324.e1. doi: 10.1016/j.anai.2015.05.017. Epub 2015 Jun 11.
Acupuncture for seasonal allergic rhinitis: a randomized controlled trial.
Xue CC, Zhang AL, Zhang CS, DaCosta C, Story DF, Thien FC.
Public notes

Contacts
Principal investigator
Name 29596 0
Prof Charlie Changli Xue
Address 29596 0
School of Health Sciences, RMIT University, Australia
Country 29596 0
Australia
Phone 29596 0
+61399257745
Fax 29596 0
Email 29596 0
[email protected]
Contact person for public queries
Name 12843 0
Dr Dr Tony Zhang
Address 12843 0
Discipline of Chinese Medicine, School of Health Sciences, RMIT University, Australia
Country 12843 0
Australia
Phone 12843 0
+61399257758
Fax 12843 0
+61 3 99257178
Email 12843 0
[email protected]
Contact person for scientific queries
Name 3771 0
Prof Prof. Charlie Xue
Address 3771 0
WHO Collaborating Center for Traditional Medicine, RMIT University, PO Box 71, Bundoora, VIC 3083
Country 3771 0
Australia
Phone 3771 0
+61 3 99257745
Fax 3771 0
+61 3 99257178
Email 3771 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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