Thread Embedding Acupuncture For Rhinitis Allergy

NCT ID: NCT06858137

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-07-31

Brief Summary

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Rhinitis allergy is chronic non-communicable disease with a rapid increase in the number of patients since 1990s. Rhinitis allergy is one of the risk factors for various chronic others including asthma, sinusitis, otitis media, as well as some conditions sleep disorders, emotional disorders related.

There are numerous pharmacological and non-pharmacological therapies that have been employed in management of these condition. Among them, thread embedding acupuncture (TEA) has been a widely used and established method for various chronic diseases, demonstrating its effectiveness, safety, and convenience. Several studies have shown a significant increase in treatment when combining TEA with pharmacological or other acupuncture therapies. However, there is currently no substantial data on the application of TEA for rhinitis allergy treatment.

This study is conducted to assess the efficacy and safety of combining TEA with inhaled corticosteroid (INCS) compared with ICS monotherapy in rhinitis allergy

Detailed Description

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Eligible participants with rhinitis allergy, defined according to the criteria set by Allergic Rhinitis and its Impact on Asthma (ARIA) 2008, will be enrolled and subsequently randomized into two groups: the intervention group (TEA + INCS group) and the control group (INCS), with a 1:1 allocation ratio.

In both groups, the intervention duration is four weeks, with inhaled corticosteroid (INCS) - fluticasone propionate used for four weeks in required and life style changing. For the intervention group, thread embedding acupuncture (TEA) therapy will be added every two weeks, totaling two sessions during the four-week period.

Data regarding number of symptoms, BMI, Visual Analogue Scale (VAS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Relief medication score and adverse effects will be recorded immediately following randomization and weekly thereafter over the eight-week duration.

Conditions

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Rhinitis Allergic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The physician responsible for administering the treatments will be aware of the group assignments but remain uninvolved in the evaluation of outcomes and subsequent data analysis. Those responsible for outcome assessment and data analysis will be kept blinded to the treatment assignments.

Study Groups

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Thread embedding acupuncture + fluticasone propionate spray

Thread embedding acupuncture (TEA) every two weeks in four weeks (two sessions). Combined with fluticasone propionate spray (INCS) when needed in four weeks and lifestyle changing

Group Type EXPERIMENTAL

Thread embedding acupuncture

Intervention Type OTHER

Thread embedding acupuncture is performed every two weeks in four weeks using a single Polydioxaone thread. Needles have a gauge size of 30G, a shaft length of 26mm, folded in half, and are applied to nine acupoints, including Yintang (EX-HN3), Yingxiang (LI20) on both sides of the body. Needles with a gauge size of 29G, a shaft length of 30mm, and a thread length of 50mm, folded in half, are used for three acupoints, which included Hegu (LI4), Zusanli (ST36), Feishu (BL13), on both sides of the body. After the thread being inserted into the body, the needle will be withdrawn immediately.

Standal treatment

Intervention Type OTHER

Inhaled corticosteroid spray - fluticasone propionate patients were permitted to use Fluticasone propionate 1 or 2 sprays (50 mcg/spray) in each nostril once a day as needed in four weeks and participants must change life style attaches including smoke and traffic pollution avoidant, preventing pets going into the bedroom, washing clothes.

fluticasone propionate spray

Fluticasone propionate when needed in four weeks combined lifestyle changing

Group Type ACTIVE_COMPARATOR

Standal treatment

Intervention Type OTHER

Inhaled corticosteroid spray - fluticasone propionate patients were permitted to use Fluticasone propionate 1 or 2 sprays (50 mcg/spray) in each nostril once a day as needed in four weeks and participants must change life style attaches including smoke and traffic pollution avoidant, preventing pets going into the bedroom, washing clothes.

Interventions

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Thread embedding acupuncture

Thread embedding acupuncture is performed every two weeks in four weeks using a single Polydioxaone thread. Needles have a gauge size of 30G, a shaft length of 26mm, folded in half, and are applied to nine acupoints, including Yintang (EX-HN3), Yingxiang (LI20) on both sides of the body. Needles with a gauge size of 29G, a shaft length of 30mm, and a thread length of 50mm, folded in half, are used for three acupoints, which included Hegu (LI4), Zusanli (ST36), Feishu (BL13), on both sides of the body. After the thread being inserted into the body, the needle will be withdrawn immediately.

Intervention Type OTHER

Standal treatment

Inhaled corticosteroid spray - fluticasone propionate patients were permitted to use Fluticasone propionate 1 or 2 sprays (50 mcg/spray) in each nostril once a day as needed in four weeks and participants must change life style attaches including smoke and traffic pollution avoidant, preventing pets going into the bedroom, washing clothes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Those not participating in any other clinical trial
* Those who provide written informed consent
* Those with typical symptoms of AR, rhinorrhea, sneezing, nasal obstruction, and pruritus. These symptoms should last at least one hour most day since last two week.

Exclusion Criteria

* Pregnancy, lactation, or recent childbirth within the past 6 months.
* Those were receiving immune therapy
* Those with other allergic diseases such as bronchial asthma or allergic purpura
* Those with nasal polyposis
* Those with heterologous protein allergy
* Those with other disorders such as AIDS, vascular malformation, hypertension, hematologic, diseases, diabetes mellitus, malignant tumor, or mental disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role lead

Responsible Party

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Bui Pham Minh Man

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Medical Center HCMC - Branch no.3

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

References

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Reference Type BACKGROUND
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Demoly P, Bousquet PJ, Mesbah K, Bousquet J, Devillier P. Visual analogue scale in patients treated for allergic rhinitis: an observational prospective study in primary care: asthma and rhinitis. Clin Exp Allergy. 2013 Aug;43(8):881-8. doi: 10.1111/cea.12121.

Reference Type BACKGROUND
PMID: 23889242 (View on PubMed)

Du SH, Guo W, Yang C, Chen S, Guo SN, Du S, Du ZM, Fei YT, Zhao JP. Filiform needle acupuncture for allergic rhinitis: A systematic review and meta-analysis. J Integr Med. 2022 Nov;20(6):497-513. doi: 10.1016/j.joim.2022.08.004. Epub 2022 Aug 24.

Reference Type BACKGROUND
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Huang JJ, Liang JQ, Xu XK, Xu YX, Chen GZ. Safety of Thread Embedding Acupuncture Therapy: A Systematic Review. Chin J Integr Med. 2021 Dec;27(12):947-955. doi: 10.1007/s11655-021-3443-1. Epub 2021 Apr 24.

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Zhang J, Zhang Y, Huang X, Lan K, Hu L, Chen Y, Yu H. Different Acupuncture Therapies for Allergic Rhinitis: Overview of Systematic Reviews and Network Meta-Analysis. Evid Based Complement Alternat Med. 2020 Apr 23;2020:8363027. doi: 10.1155/2020/8363027. eCollection 2020.

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Reference Type BACKGROUND
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Sheng J, Jin X, Zhu J, Chen Y, Liu X. The Effectiveness of Acupoint Catgut Embedding Therapy for Abdominal Obesity: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2019 Jun 23;2019:9714313. doi: 10.1155/2019/9714313. eCollection 2019.

Reference Type BACKGROUND
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Ozdoganoglu T, Songu M, Inancli HM. Quality of life in allergic rhinitis. Ther Adv Respir Dis. 2012 Feb;6(1):25-39. doi: 10.1177/1753465811424425. Epub 2011 Oct 27.

Reference Type BACKGROUND
PMID: 22032987 (View on PubMed)

Li X, Liu Y, Zhang Q, Xiang N, He M, Zhong J, Chen Q, Wang X. Effect of catgut implantation at acupoints for the treatment of allergic rhinitis: a randomized, sham-controlled trial. BMC Complement Altern Med. 2016 Nov 10;16(1):454. doi: 10.1186/s12906-016-1400-x.

Reference Type BACKGROUND
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Meltzer EO, Wallace D, Friedman HS, Navaratnam P, Scott EP, Nolte H. Meta-analyses of the efficacy of pharmacotherapies and sublingual allergy immunotherapy tablets for allergic rhinitis in adults and children. Rhinology. 2021 Oct 1;59(5):422-432. doi: 10.4193/Rhin21.054.

Reference Type BACKGROUND
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Larenas-Linnemann DES, Domthong P, Di Francesco RC, Gonzalez-Perez R, Verma M. General practitioner and patient perspectives on intranasal corticosteroids for allergic rhinitis: Treatment duration and obstacles to adherence, findings from a recent survey. World Allergy Organ J. 2024 Jun 25;17(7):100925. doi: 10.1016/j.waojou.2024.100925. eCollection 2024 Jul.

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Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.

Reference Type BACKGROUND
PMID: 20816182 (View on PubMed)

Seidman MD, Gurgel RK, Lin SY, Schwartz SR, Baroody FM, Bonner JR, Dawson DE, Dykewicz MS, Hackell JM, Han JK, Ishman SL, Krouse HJ, Malekzadeh S, Mims JW, Omole FS, Reddy WD, Wallace DV, Walsh SA, Warren BE, Wilson MN, Nnacheta LC; Guideline Otolaryngology Development Group. AAO-HNSF. Clinical practice guideline: Allergic rhinitis. Otolaryngol Head Neck Surg. 2015 Feb;152(1 Suppl):S1-43. doi: 10.1177/0194599814561600.

Reference Type BACKGROUND
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Other Identifiers

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2466/ĐHYD-HDDD

Identifier Type: -

Identifier Source: org_study_id

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