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Trial record 1 of 1 for:    NCT05709977
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Acupuncture for Nasal Congestion in Allergic Rhinitis (ANCAR)

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ClinicalTrials.gov Identifier: NCT05709977
Recruitment Status : Recruiting
First Posted : February 2, 2023
Last Update Posted : March 17, 2023
Sponsor:
Collaborators:
Nanjing University of Chinese Medicine
Mermaid Medicine®
Information provided by (Responsible Party):
Johanna Maria Vermeulen, Mermaid Medicine®

Study Description
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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 Not Applicable

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-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)
Estimated Study Start Date : March 7, 2023
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Intranasal antihistamine (INAH) therapy


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed AR by a physician
  • Have one 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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05709977


Contacts
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Contact: Johanna M. Vermeulen, BSc., L.Ac. 0031-(0)70-3694787 info@mermaidmedicine.com

Locations
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Netherlands
Mermaid Medicine® Recruiting
Den Haag, Zuid-Holland, Netherlands, 2492 NC
Contact: Johanna M. Vermeulen, BSc., L.Ac.    0031-(0)70-3694787    info@mermaidmedicine.com   
Principal Investigator: Johanna M. Vermeulen, BSc., L.Ac.         
Sponsors and Collaborators
Johanna Maria Vermeulen
Nanjing University of Chinese Medicine
Mermaid Medicine®
Investigators
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Principal Investigator: Johanna M. Vermeulen, BSc., L.Ac. Mermaid Medicine®
More Information
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Additional Information:

Publications:
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.
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.

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Responsible Party: Johanna Maria Vermeulen, Principal Investigator, Mermaid Medicine®
ClinicalTrials.gov Identifier: NCT05709977    
Other Study ID Numbers: ANCAR Trial
First Posted: February 2, 2023    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 3 months following publication, ending 3 years following article publication.
Access Criteria: Access to trial IPD can be requested by a qualified researcher engaging in independent scientific research.
URL: https://www.mermaidmedicine.com

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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
Keywords provided by Johanna Maria Vermeulen, Mermaid Medicine®:
Acupuncture
Nasal Congestion
Allergic Rhinitis
Randomized
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Histamine Antagonists
Histamine H1 Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs