Acupuncture for Nasal Congestion in Allergic Rhinitis (ANCAR)

February 21, 2026 updated by: Johanna Maria Vermeulen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • South Holland
      • The Hague, South Holland, Netherlands, 2492 NC
        • Mermaid Medicine®

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture arm
Fixed set of acupuncture points
Other: Acupuncture
Fixed set of acupuncture points
Active Comparator: Control (Carelastin®) arm
Carelastin® (1 mg/ml) azelastine nasal spray, 1 spray puff (0.14 ml) per nostril twice daily (totally 0.56 ml per day)
Drug: Antihistamine nasal spray
Carelastin® (1 mg/ml) azelastine nasal spray
Other Names:
  • Intranasal antihistamine (INAH) therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: At 1st day (visit 1), During 6 weeks of treatments (visit 2-7: Only acupuncture arm), 2 weeks after treatment protocol (visit 9), and 2 months after treatment protocol (visit 10).
To compare the effects of acupuncture and azelastine nasal spray (Carelastin®) on nasal congestion in AR after different visits of treatments based on VAS score. VAS, 0 = no nasal congestion, and 10 = most severe nasal congestion.
At 1st day (visit 1), During 6 weeks of treatments (visit 2-7: Only acupuncture arm), 2 weeks after treatment protocol (visit 9), and 2 months after treatment protocol (visit 10).
Peak Nasal Inspiratory Flow (PNIF)
Time Frame: At 1st day (visit 1), After 6 weeks (visit 8), 2 weeks after treatment protocol (visit 9), and 2 months after treatment protocol (visit 10).
To compare the effects of acupuncture and azelastine nasal spray (Carelastin®) on nasal congestion in AR after different visits of treatments based on PNIF score (score ranges between 30-370 L/min).
At 1st day (visit 1), After 6 weeks (visit 8), 2 weeks after treatment protocol (visit 9), and 2 months after treatment protocol (visit 10).
Adapted Nasal Obstruction Symptom Evaluation (NOSE)
Time Frame: After 6 weeks (visit 8), and 2 months after treatment protocol (visit 10).
To compare the effects of acupuncture and azelastine nasal spray (Carelastin®) on nasal congestion in AR after different visits of treatments based on Adapted NOSE score. NOSE, 0 = no problem, and 4 = severe problem.
After 6 weeks (visit 8), and 2 months after treatment protocol (visit 10).
Visual Analog Scale (VAS)
Time Frame: At 1st day (visit 1), During 6 weeks of treatments (visit 2-7: Only acupuncture arm), After 6 weeks (visit 8), 2 weeks after treatment protocol (visit 9), and 2 months after treatment protocol (visit 10).
To assess the effects of acupuncture on other nasal and ocular signs and symptoms in AR based on VAS score. VAS, 0 = no symptom, and 10 = most severe symptom.
At 1st day (visit 1), During 6 weeks of treatments (visit 2-7: Only acupuncture arm), After 6 weeks (visit 8), 2 weeks after treatment protocol (visit 9), and 2 months after treatment protocol (visit 10).
Adapted Nasal Obstruction Symptom Evaluation (NOSE)
Time Frame: After 6 weeks (visit 8), and 2 months after treatment protocol (visit 10).
To assess the effects of acupuncture on general health, concentration and energy level in AR after different visits of treatments based on Adapted NOSE score. NOSE, 0 = excellent, and 4 = poor.
After 6 weeks (visit 8), and 2 months after treatment protocol (visit 10).
Adapted Nasal Obstruction Symptom Evaluation (NOSE)
Time Frame: After 6 weeks (visit 8), and 2 months after treatment protocol (visit 10).
To assess the effects of acupuncture on equalization of middle ear pressure in AR in the case patients fly and/or dive after different visits of treatments based on adapted NOSE score. NOSE, 0 = no problem, 4 = severe problem, and 99 = not applicable.
After 6 weeks (visit 8), and 2 months after treatment protocol (visit 10).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johanna Maria Vermeulen

Collaborators

Mermaid Medicine®
Affiliated Hospital of Nanjing University of Chinese Medicine

Investigators

  • Principal Investigator: Johanna M. Vermeulen, BSc., L.Ac., Mermaid Medicine®

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Actual)

November 7, 2023

Study Completion (Actual)

December 22, 2023

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

February 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANCAR Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

3 months following publication, ending 3 years following article publication.

IPD Sharing Access Criteria

Access to trial IPD can be requested by a qualified researcher engaging in independent scientific research.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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