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Acupuncture for Nasal Congestion in Allergic Rhinitis

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05709977
Acronym
ANCAR
Enrollment
11
Registered
2023-02-02
Start date
2023-04-20
Completion date
2023-12-22
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Acupuncture, Nasal Congestion, Allergic Rhinitis, azelastine nasal spray, randomized controlled trial

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.

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.

Interventions

OTHERAcupuncture

Fixed set of acupuncture points

DRUGAntihistamine nasal spray

Carelastin® (1 mg/ml) azelastine nasal spray

Sponsors

Johanna Maria Vermeulen
Lead SponsorOTHER
Affiliated Hospital of Nanjing University of Chinese Medicine
CollaboratorOTHER
Mermaid Medicine®
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Open-Label, Randomized, Controlled, Interventional, Monocenter Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Visual Analog Scale (VAS) From Baseline to 6 Weeks (6-week Value Compared to Baseline Value)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.

Countries

Netherlands

Contacts

PRINCIPAL_INVESTIGATORJohanna M. Vermeulen, BSc., L.Ac.

Mermaid Medicine®

Participant flow

Recruitment details

The first participant was enrolled on April 20, 2023. Between April and September 2023, a total of 10 eligible participants were recruited. Recruitment efforts involved distributing promotional materials via e-mail and postal mail to 200 physicians in the vicinity of Mermaid Medicine®.

Pre-assignment details

11 participants were enrolled; however, 1 participant was found to be ineligible. Therefore, a total of 10 eligible participants were enrolled.

Baseline characteristics

Characteristic
Age, Continuous44 years
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 40 / 6
other
Total, other adverse events
0 / 40 / 6
serious
Total, serious adverse events
0 / 40 / 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026