Rhinitis AllergicNCT06858137

Thread Embedding Acupuncture For Rhinitis Allergy

A study testing Thread embedding acupuncture and Standal treatment in people with Rhinitis Allergic, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Rhinitis Allergic
What is being tested?: Thread embedding acupuncture and Standal treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteVietnam
Study dates: 15 Mar 2025to 31 Aug 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

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

Other trials in Vietnam

About this study

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

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

Read the 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.

Conditions: Rhinitis Allergic
Being tested: Thread embedding acupuncture, Standal treatment
Keywords: Rhinitis allergic, thread embedding acupuncture, traditional medicine
Medical subject headings: Rhinitis, Allergic, Perennial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Thread embedding acupunctureOther
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 treatmentOther
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.

Study groups in NCT06858137
Study group	Role	What they receive
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 Receives: Other: Thread embedding acupuncture; Other: Standal treatment
fluticasone propionate spray	Active comparator	Fluticasone propionate when needed in four weeks combined lifestyle changing Receives: Other: Standal treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202531 Aug 2025

First posted5 Mar 2025
Study start15 Mar 2025
Primary completion31 Jul 2025
Study completion31 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Rhinitis AllergicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06858137
Sponsor's protocol ID: 2466/ĐHYD-HDDD
Status last verified: Jun 2026
First submitted: 27 Feb 2025
Last updated: 9 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 8876562
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.
PubMed 23889242
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.
PubMed 36068161
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.
PubMed 33893986
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.
PubMed 32382307
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.
PubMed 35693255
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.
PubMed 31341504
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.
PubMed 22032987
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.
PubMed 27829410
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.
PubMed 34463311
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.
PubMed 39035787
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.
PubMed 20816182
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.
PubMed 25644617

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rhinitis Allergic trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Thread Embedding Acupuncture for Rhinitis Allergy: Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06858137
Acronym / sponsor ID: 2466/ĐHYD-HDDD
Conditions: Rhinitis Allergic
Keywords: Rhinitis allergic, thread embedding acupuncture, traditional medicine
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
Study start: 15 Mar 2025 (actual)
Primary completion: 31 Jul 2025 (actual)
Study completion: 31 Aug 2025 (actual)
First posted: 5 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Thread embedding acupuncture + fluticasone propionate spray	Experimental	Other: Thread embedding acupuncture, Other: Standal treatmentThread 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
fluticasone propionate spray	Active comparator	Other: Standal treatmentFluticasone propionate when needed in four weeks combined lifestyle changing

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thread embedding acupunctureThread 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	Thread embedding acupuncture + fluticasone propionate spray
Standal treatmentInhaled 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.	Other	Thread embedding acupuncture + fluticasone propionate spray, fluticasone propionate spray

Primary outcome

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.

3 secondary outcomes

Changes in quality of life
Time frame: Assessments conducted at randomization and after two-week period (Week 0, Week 2, Week 6, Week 8)
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)
Proportion of intervention-related adverse effects
Time frame: Up to eight weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Background: PubMed 8876562Juniper 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.
Background: PubMed 23889242Demoly 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.
Background: PubMed 36068161Du 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.
Background: PubMed 33893986Huang 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.
Background: PubMed 32382307Zhang 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.
Background: PubMed 35693255Shen 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.
Background: PubMed 31341504Sheng 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.
Background: PubMed 22032987Ozdoganoglu 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.
Background: PubMed 27829410Li 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.
Background: PubMed 34463311Meltzer 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.
Background: PubMed 39035787Larenas-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.
Background: PubMed 20816182Brozek 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.
Individual participant dataSharing planned: No

Related trials for Rhinitis Allergic

Not yet recruitingObservational study
Prevelance of Broncial Asthma and Allergic Rhinitis in Children With Nephrotic Syndrim
Bronchial Asthma, Allergic Rhinitis
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
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Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Thread embedding acupuncture and Standal treatment in people with Rhinitis Allergic, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06858137, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.