Acupuncture for Nasal Congestion in Allergic Rhinitis (ANCAR)

Sponsor

Johanna Maria Vermeulen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05709977

Collaborator

Nanjing University of Chinese Medicine (Other), Mermaid Medicine® (Other)

Enrollment

Location

Arms

3.3

Anticipated Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

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 remedial blueprint 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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Other: Acupuncture Drug: Antihistamine nasal spray	N/A

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. 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 remedial blueprint 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.

Endnotes: see References/Citations.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 27, 2023

Anticipated Primary Completion Date :

May 3, 2023

Anticipated Study Completion Date :

Jul 5, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual Analog Scale (VAS) [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.

Secondary Outcome Measures

Visual Analog Scale (VAS) [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.
Peak Nasal Inspiratory Flow (PNIF) [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).
Adapted Nasal Obstruction Symptom Evaluation (NOSE) [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.
Visual Analog Scale (VAS) [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.
Adapted Nasal Obstruction Symptom Evaluation (NOSE) [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.
Adapted Nasal Obstruction Symptom Evaluation (NOSE) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed AR by a physician
Seasonal (SAR) and perennial (PAR) allergic rhinitis (including mixed AR (MAR))
VAS nasal congestion: 3-10 (= moderate and severe nasal congestion)
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