Thread Embedding Acupuncture For Rhinitis Allergy

June 6, 2026 updated by: Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City

Efficacy and Safety of Thread Embedding Acupuncture for Rhinitis Allergy: Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • University of Medical Center HCMC - Branch no.3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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.
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.
Active Comparator: fluticasone propionate spray
Fluticasone propionate when needed in four weeks combined lifestyle changing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in nasal symtoms
Time Frame: Assessments conducted at randomization and after each intervention week throughout the first two-week period (Week 0, Week 1, Week 2), then Week 8.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in relief medication
Time Frame: Assessments conducted at randomization and after two-week period (Week 0, Week 2, Week 4, Week 6, Week 8)
Relief medication score including the INCS dosage per day and days per week.
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
Time Frame: Up to eight weeks

For Thread embedding acupuncture, expected AEs encompass local discomfort, post-treatment elevation in body temperature, local hematoma or subcutaneous hemorrhage, local swelling, local induration, local pain, local redness, infection, abscess, pruritus, and anaphylaxis.

Additionally, any unexpected AEs associated with these procedures will also be documented and monitored.
Up to eight weeks
Changes in quality of life
Time Frame: Assessments conducted at randomization and after two-week period (Week 0, Week 2, Week 6, Week 8)
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has 28 questions in seven domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems, and emotional function). Participants will recall to their rhinitis allergy symptoms for last two weeks to respond to each question on a seven-point scale (0 = not impaired at all; 6 = severely impaired).
Assessments conducted at randomization and after two-week period (Week 0, Week 2, Week 6, Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2025

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2466/ĐHYD-HDDD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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