Acupuncture for Nasal Congestion in Allergic Rhinitis

NCT ID: NCT05709977

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2023-12-22

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 affects the quality of life (QOL). Current medications are undesirable due to their side-effects. 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)).

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture arm

Fixed set of acupuncture points

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Fixed set of acupuncture points

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)

Group Type: ACTIVE_COMPARATOR

Antihistamine nasal spray

Intervention Type: DRUG

Carelastin® (1 mg/ml) azelastine nasal spray

Interventions

Acupuncture

Fixed set of acupuncture points

Intervention Type: OTHER

Antihistamine nasal spray

Carelastin® (1 mg/ml) azelastine nasal spray

Intervention Type: DRUG

Other Intervention Names

Intranasal antihistamine (INAH) therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine

OTHER

Sponsor Role: collaborator

Mermaid Medicine®

OTHER

Sponsor Role: collaborator

Johanna Maria Vermeulen

OTHER

Sponsor Role: lead

Responsible Party

Johanna Maria Vermeulen

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johanna M. Vermeulen, BSc., L.Ac.

Role: PRINCIPAL_INVESTIGATOR

Mermaid Medicine®

Locations

Mermaid Medicine®

The Hague, South Holland, Netherlands

Countries

Netherlands

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Related Links

https://www.mylan.nl/nl-nl/therapeutische-gebieden/allergische-rhinitis

Mylan website. Allergische rhinitis. Updated November 13, 2018. Accessed December 3, 2021. Website inactive on March 13, 2024.

Other Identifiers

ANCAR Trial

Identifier Type: -

Identifier Source: org_study_id