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Allergic RhinitisANCARNCT05709977

Acupuncture for Nasal Congestion in Allergic Rhinitis

A study testing Acupuncture and Antihistamine nasal spray in people with Allergic Rhinitis, run by Johanna Maria Vermeulen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Allergic Rhinitis
What is being tested?
Acupuncture and Antihistamine nasal spray
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteNetherlands
Study dates
20 Apr 2023to 22 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Mermaid Medicine®

    The Hague, South Holland, 2492 NC

Other trials in Netherlands

About this study

Official title: Acupuncture for Nasal Congestion in Allergic Rhinitis: An Open-Label, Randomized, Monocenter Trial (ANCAR Trial)

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.

Read the detailed description

Worldwide more than approximately 500 million people suffer from AR (30% of the Dutch population) and its prevalence is expanding. Nasal congestion (i.e. reversible mucosal congestion/nasal mucosal obstruction) is one of the most general and bothersome symptoms in rhinitis and is associated with other medical conditions such as rhinosinusitis and otitis media. This study is relevant as in addition to the high global occurrence of AR, this disorder has substantial effects on the quality of life (QOL) (e.g. during sleep and work). AR is related to high direct medical costs (mainly prescription of medications and outpatient visits) and indirect economic costs (including productivity decrease). Current medications are undesirable due to their side-effects (such as sedation in the case of intranasal antihistamines (INAH)) 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 specifically nasal congestion in AR is not verified by strictly designed clinical study. The ANCAR trial aims to evaluate the effects of an acupuncture treatment protocol for nasal congestion in AR compare to azelastine nasal spray (Carelastin®). A standard treatment protocol with a fixed set of acupuncture points has been established - to be as scientific as possible from Western medical viewpoint - and this selection of acupuncture points can be seen as a solid and profound approach from which every AR patient may benefit. This standard set opens the nose and affects the underlying energetic imbalance and immunity at the same time to maintain its nose opening effect (i.e. to prevent recurrence of the complaint). The acupuncture protocol concerns 8 treatments during 6 weeks (i.e. 2 treatments per week during the first 2 weeks and 1 treatment per week in the consecutive 4 weeks).

The positive effects of this treatment protocol (such as improvement QOL) may result in more confidence in the direct, post-treatment and long-term effects of acupuncture and lead to more acceptance of acupuncture as a solid treatment option for nasal congestion in AR instead of using an INAH spray.

Hypothesis: Acupuncture will improve nasal congestion in AR compare to azelastine nasal spray (Carelastin®).

Objective: To evaluate the effects of an acupuncture treatment protocol for nasal congestion in AR.

Being tested
Acupuncture, Antihistamine nasal spray
Keywords
Acupuncture, Nasal Congestion, Allergic Rhinitis, azelastine nasal spray, randomized controlled trial
Medical subject headings
Rhinitis, Allergic, Nasal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureOther

    Fixed set of acupuncture points

  • Antihistamine nasal sprayDrug

    Also called Intranasal antihistamine (INAH) therapy

    Carelastin® (1 mg/ml) azelastine nasal spray

Study groups in NCT05709977
Study groupRoleWhat they receive
Acupuncture armExperimentalFixed set of acupuncture points
Receives: Other: Acupuncture
Control (Carelastin®) armActive comparatorCarelastin® (1 mg/ml) azelastine nasal spray, 1 spray puff (0.14 ml) per nostril twice daily (totally 0.56 ml per day)
Receives: Drug: Antihistamine nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: After 6 weeks (visit 8).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start20 Apr 2023
  3. Primary completion7 Nov 2023
  4. Study completion22 Dec 2023

Resources

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
Model description
Open-Label, Randomized, Controlled, Interventional, Monocenter Trial
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05709977
Sponsor's protocol ID
ANCAR Trial
Acronym
ANCAR
Status last verified
Feb 2026
First submitted
10 Jan 2023
Last updated
13 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 18219828
  • Bousquet 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.

    PubMed 18331513
  • Kjaergaard 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.

    PubMed 19507219
  • Ichimura 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.

  • Lieberman 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.

    PubMed 15899111
  • Craig 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.

    PubMed 20425503
  • Skoner DP. Complications of allergic rhinitis. J Allergy Clin Immunol. 2000 Jun;105(6 Pt 2):S605-9. doi: 10.1067/mai.2000.106150.

    PubMed 10856165
  • Bousquet 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.

    PubMed 23183377
  • Law 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.

    PubMed 12589348
  • Wallace 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.

    PubMed 18662584
  • Sertel 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.

    PubMed 19769799

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture and Antihistamine nasal spray in people with Allergic Rhinitis, run by Johanna Maria Vermeulen at 1 site in Netherlands.

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 5 inclusion and 12 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: finished, as of the sponsor's last update on 13 Mar 2026. 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 Netherlands. 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?

Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Analog Scale (VAS) From Baseline to 6 Weeks (6-week Value Compared to Baseline Value) (time frame: After 6 weeks (visit 8).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05709977, which also lists 11 linked publications.

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 13 Mar 2026.

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