Study Results
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Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2024-12-15
2025-07-31
Brief Summary
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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
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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
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.
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.
fluticasone propionate spray
Fluticasone propionate when needed in four weeks combined lifestyle changing
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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University of Medicine and Pharmacy at Ho Chi Minh City
OTHER
Responsible Party
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Bui Pham Minh Man
Principal Investigator
Locations
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University of Medical Center HCMC - Branch no.3
Ho Chi Minh City, , Vietnam
Countries
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References
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Juniper EF, Guyatt GH, Griffith LE, Ferrie PJ. Interpretation of rhinoconjunctivitis quality of life questionnaire data. J Allergy Clin Immunol. 1996 Oct;98(4):843-5. doi: 10.1016/s0091-6749(96)70135-5. No abstract available.
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.
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.
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.
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.
Shen M, Liu J, Wang K. Effect of Traditional Chinese Medicine on Allergic Rhinitis in Children under Data Mining. Comput Math Methods Med. 2022 Jun 1;2022:7007370. doi: 10.1155/2022/7007370. eCollection 2022.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2466/ĐHYD-HDDD
Identifier Type: -
Identifier Source: org_study_id
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