Acupuncture for Nasal Congestion in Allergic Rhinitis
ANCAR
1 other identifier
interventional
11
1 country
1
Brief Summary
Allergic rhinitis (AR) is a disorder that affects more than 500 million people worldwide. Nasal congestion is one of the most general and bothersome symptoms in rhinitis, which impacts the quality of life (QOL). Current medications are undesirable due to their side-effects and there are AR patients who perceive inadequate responses despite to advancements in conventional medicine. Acupuncture for AR in general can be considered as safe and can be seen as a potential therapeutic intervention for nasal congestion. Evidence supported that acupuncture is clinically used for signs and symptoms of nose disorders, such as nasal congestion, with effectiveness, but whether acupuncture has immediate, post-treatment and long-term effects on nasal congestion in AR is not verified by strictly designed clinical study. The ANCAR trial uses a standard treatment protocol with a fixed set of acupuncture points - to be as scientific as possible from Western medical viewpoint - to open the nose and affect underlying energetic imbalance and immunity at the same time, to maintain its nose opening effect. This novel acupuncture treatment protocol can be seen as a solid and profound approach from which every AR patient may benefit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2023
CompletedStudy Start
First participant enrolled
April 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2023
CompletedResults Posted
Study results publicly available
March 13, 2026
CompletedMarch 13, 2026
February 1, 2026
7 months
January 10, 2023
January 17, 2026
February 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Visual Analog Scale (VAS) From Baseline to 6 Weeks (6-week Value Compared to Baseline Value)
To compare the effects of acupuncture and azelastine nasal spray (Carelastin®) on nasal congestion in AR after 6 weeks of treatments based on VAS score. VAS, 0 = no nasal congestion, and 10 = most severe nasal congestion.
After 6 weeks (visit 8).
Study Arms (2)
Acupuncture arm
EXPERIMENTALFixed set of acupuncture points
Control (Carelastin®) arm
ACTIVE COMPARATORCarelastin® (1 mg/ml) azelastine nasal spray, 1 spray puff (0.14 ml) per nostril twice daily (totally 0.56 ml per day)
Interventions
Carelastin® (1 mg/ml) azelastine nasal spray
Eligibility Criteria
You may qualify if:
- Diagnosed AR by a physician
- Have one of the AR types: seasonal (SAR) or perennial (PAR) or mixed (MAR) allergic rhinitis
- VAS nasal congestion: 3-10
- Age: from 18 years
- Signed Informed Consent
You may not qualify if:
- COVID-19
- Acute common cold
- Influenza
- Fever (38°C or higher)
- Acute nasal trauma (such as a fracture and epistaxis)
- Irreversible nasal blockages (such as septum deviation, concha bullosa, polyps and cysts)
- Nasal and sinus cancer
- Pregnancy or planning for pregnancy
- Consumed decongestions, antihistamines, antibiotics or corticosteroids within 2 weeks before the RCT
- Received acupuncture, Chinese herbal medicine or another complementary treatment within 2 weeks before the RCT
- Received immunotherapy within 2 weeks before the RCT
- Participants refusing or unable to sign Informed Consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johanna Maria Vermeulenlead
- Affiliated Hospital of Nanjing University of Chinese Medicinecollaborator
- Mermaid Medicine®collaborator
Study Sites (1)
Mermaid Medicine®
The Hague, South Holland, 2492 NC, Netherlands
Related Publications (11)
Guo R, Pittler MH, Ernst E. Herbal medicines for the treatment of allergic rhinitis: a systematic review. Ann Allergy Asthma Immunol. 2007 Dec;99(6):483-95. doi: 10.1016/S1081-1206(10)60375-4.
PMID: 18219828BACKGROUNDBousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D; World Health Organization; GA(2)LEN; AllerGen. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160. doi: 10.1111/j.1398-9995.2007.01620.x. No abstract available.
PMID: 18331513BACKGROUNDKjaergaard T, Cvancarova M, Steinsvag SK. Nasal congestion index: A measure for nasal obstruction. Laryngoscope. 2009 Aug;119(8):1628-32. doi: 10.1002/lary.20505.
PMID: 19507219BACKGROUNDIchimura K. Mechanism of nasal obstruction in patients with allergic rhinitis. Clin Exp Allergy. 2010;10(1):20-27. https://doi.org/10.1111/j.1472-9733.2010.01151.x.
BACKGROUNDLieberman P, Kaliner MA, Wheeler WJ. Open-label evaluation of azelastine nasal spray in patients with seasonal allergic rhinitis and nonallergic vasomotor rhinitis. Curr Med Res Opin. 2005 Apr;21(4):611-8. doi: 10.1185/030079905X41408.
PMID: 15899111BACKGROUNDCraig TJ, Sherkat A, Safaee S. Congestion and sleep impairment in allergic rhinitis. Curr Allergy Asthma Rep. 2010 Mar;10(2):113-21. doi: 10.1007/s11882-010-0091-5.
PMID: 20425503BACKGROUNDSkoner DP. Complications of allergic rhinitis. J Allergy Clin Immunol. 2000 Jun;105(6 Pt 2):S605-9. doi: 10.1067/mai.2000.106150.
PMID: 10856165BACKGROUNDBousquet PJ, Demoly P, Devillier P, Mesbah K, Bousquet J. Impact of allergic rhinitis symptoms on quality of life in primary care. Int Arch Allergy Immunol. 2013;160(4):393-400. doi: 10.1159/000342991. Epub 2012 Nov 23.
PMID: 23183377BACKGROUNDLaw AW, Reed SD, Sundy JS, Schulman KA. Direct costs of allergic rhinitis in the United States: estimates from the 1996 Medical Expenditure Panel Survey. J Allergy Clin Immunol. 2003 Feb;111(2):296-300. doi: 10.1067/mai.2003.68.
PMID: 12589348BACKGROUNDWallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, Lang DM, Nicklas RA, Oppenheimer J, Portnoy JM, Randolph CC, Schuller D, Spector SL, Tilles SA; Joint Task Force on Practice; American Academy of Allergy; Asthma & Immunology; American College of Allergy; Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunol. 2008 Aug;122(2 Suppl):S1-84. doi: 10.1016/j.jaci.2008.06.003. No abstract available.
PMID: 18662584BACKGROUNDSertel S, Bergmann Z, Ratzlaff K, Baumann I, Greten HJ, Plinkert PK. Acupuncture for nasal congestion: a prospective, randomized, double-blind, placebo-controlled clinical pilot study. Am J Rhinol Allergy. 2009 Nov-Dec;23(6):e23-8. doi: 10.2500/ajra.2009.23.3380. Epub 2009 Sep 18.
PMID: 19769799BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The ANCAR trial encountered crucial recruitment challenges mainly due to COVID-19 pandemic and the fact that acupuncture is not part of regular medicine in The Netherlands , leading to a much lower patient count than initially anticipated.
Results Point of Contact
- Title
- Johanna Maria Vermeulen
- Organization
- Mermaid Medicine®
Study Officials
- PRINCIPAL INVESTIGATOR
Johanna M. Vermeulen, BSc., L.Ac.
Mermaid Medicine®
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 10, 2023
First Posted
February 2, 2023
Study Start
April 20, 2023
Primary Completion
November 7, 2023
Study Completion
December 22, 2023
Last Updated
March 13, 2026
Results First Posted
March 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 3 months following publication, ending 3 years following article publication.
- Access Criteria
- Access to trial IPD can be requested by a qualified researcher engaging in independent scientific research.
IPD that underlies the results reported in this article after deidentification (text, tables, figures and appendixes) for qualified researchers. Approval of the request is a prerequisite to the sharing of data.