Thread Embedding Acupuncture For Rhinitis Allergy

NCT06858137 | Completed

• 1 other identifier: 2466/ĐHYD-HDDD
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rhinitis Allergic

Keywords

Rhinitis allergic; thread embedding acupuncture; traditional medicine

Outcome Measures

Primary Outcomes (1)

• Changes in nasal symtoms

  Visual analogue scale (VAS) consists of a 100mm long line, ranging from "no troublesome at all" to "very troublesome" AR patients mark a point that best corresponds to the severity of their symptoms since a week before or current status of disease control. Participants will mark the position on the scale that corresponds to their current.

  Assessments conducted at randomization and after each intervention week throughout the first two-week period (Week 0, Week 1, Week 2), then Week 8.

Secondary Outcomes (3)

• Changes in quality of life

  Assessments conducted at randomization and after two-week period (Week 0, Week 2, Week 6, Week 8)

• Changes in relief medication

  Assessments conducted at randomization and after two-week period (Week 0, Week 2, Week 4, Week 6, Week 8)

• Proportion of intervention-related adverse effects

  Up to eight weeks

Study Arms (2)

Thread embedding acupuncture + fluticasone propionate spray

EXPERIMENTAL

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

Other: Thread embedding acupuncture; Other: Standal treatment

fluticasone propionate spray

ACTIVE COMPARATOR

Fluticasone propionate when needed in four weeks combined lifestyle changing

Other: Standal treatment

Interventions

Thread embedding acupuncture 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.

Thread embedding acupuncture + fluticasone propionate spray

Standal treatment 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.

Thread embedding acupuncture + fluticasone propionate spray; fluticasone propionate spray

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University of Medical Center HCMC - Branch no.3

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (13)

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  PMID: 36068161 BACKGROUND

• 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.

  PMID: 33893986 BACKGROUND

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  PMID: 32382307 BACKGROUND

• 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.

  PMID: 35693255 BACKGROUND

• 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.

  PMID: 31341504 BACKGROUND

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  PMID: 27829410 BACKGROUND

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  PMID: 34463311 BACKGROUND

• 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.

  PMID: 39035787 BACKGROUND

• 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.

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• 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.

  PMID: 25644617 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: December 15, 2024
• Primary Completion: April 15, 2025
• Study Completion: July 31, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)