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ItchingNCT06323304

Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis

A study testing Auricular acupressure and Standard treatment in people with Itching and Runny Nose, 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
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Trial summary

Allergic rhinitis (AR) is a global health problem affecting approximately 10% to 40% of the population worldwide, with an increasing trend. It significantly impacts health and quality of life. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Itching, Runny Nose, Sneezing
What is being tested?
Auricular acupressure and Standard treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteVietnam
Study dates
13 Mar 2024to 30 Aug 2024
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients must be diagnosed with allergic rhinitis according to the ARIA 2019 (Allergic Rhinitis and its Impact on Asthma) diagnostic criteria, must be between 18 and 60 years old.
  • Must have had typical symptoms of allergic rhinitis for at least 2 years.
  • Must provide written informed consent to participate in the study.
  • Must be mentally alert and able to communicate effectively.
  • Must have vital signs within normal limits (pulse, blood pressure, temperature, respiratory rate, SpO2).
  • Must not have any other chronic diseases, including respiratory diseases (asthma, pneumonia, chronic obstructive pulmonary disease, etc.), thyroid disease, autonomic nervous system disorders, hypertension, or diabetes, as determined by medical history.
  • Must not have any knowledge of auricular therapy.

Who cannot join

  • Have used decongestants, antihistamines, anticholinergics, or oral corticosteroids within the past 1 week.
  • Have undergone auricular acupuncture, auricular acupressure, or other forms of acupuncture for the treatment of other respiratory diseases within the past 6 months.
  • Have used stimulants (alcohol, beer, coffee, tobacco) within 24 hours of the study.
  • Lesions (scars, tears, scratches, bites) on the left auricle.
  • Allergic rhinitis with secondary infection, acute sinusitis or acute exacerbation of chronic sinusitis, or chronic sinusitis.

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: Evaluating Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis: A Randomized Controlled Trial

Allergic rhinitis (AR) is a global health problem affecting approximately 10% to 40% of the population worldwide, with an increasing trend. It significantly impacts health and quality of life. Current treatments for AR include allergen avoidance, symptom-relieving medications, anti-inflammatory therapy, and allergen-specific immunotherapy. However, many patients still experience uncontrolled symptoms despite these approaches, either as monotherapy or in combination, along with medication side effects such as drowsiness, dry eyes, nasal mucosal damage, and immunosuppression.

Auricular acupressure therapy (AAT) utilizes ear acupoints by applying pressure with ear seeds. The neurobiological mechanisms of AAT on the human body have gained increasing attention in clinical and experimental studies, involving anti-inflammatory, antioxidant, and immunomodulatory effects. Its efficacy has been recognized, becoming a potential alternative therapy for various conditions such as sleep disorders, obesity, and chronic pain. Previous clinical studies have reported the efficacy and safety of AAT in treating AR. However, the primary outcomes of these studies remain inconsistent and lack specific criteria for evaluating AR treatment efficacy.

This study aims to investigate the efficacy and safety of AAT in treating AR based on the ARIA guideline 2019 treatment efficacy criteria. It will provide a basis for applying AAT as a complementary approach in the multimodal treatment of AR.

Read the detailed description

Patients with allergic rhinitis who have typical symptoms such as nasal itching, runny nose, sneezing, nasal congestion, and are indicated for corticosteroid nasal spray according to the ARIA 2019 diagnostic and treatment guidelines will be registered for this study. They will then be randomly assigned to two groups: Intervention group (auricular acupressure therapy + fluticasone propionate nasal spray), and control group (sham auricular acupressure therapy + fluticasone propionate nasal spray). The allocation ratio for the two groups is 1:1.

The intervention period for both groups is four weeks. Auricular acupressure therapy or sham acupressure therapy will be performed every week. Fluticasone propionate nasal spray will be used whenever symptoms occur. Patients will also be encouraged to adjust their lifestyle and living environment.

Data on the severity of allergic rhinitis symptoms (including nasal itching, sneezing, runny nose, nasal congestion, eye symptoms, and headache), the Rhinitis Quality of Life Questionnaire (RQLQ), and side effects of auricular acupressure therapy will be recorded before the study and weekly for 4 weeks.

Being tested
Auricular acupressure, Sham acupressure, Standard treatment
Keywords
Allergic rhinitis, Auricular acupressure therapy, Traditional medicine
Medical subject headings
Pruritus, Rhinorrhea, Sneezing, Nasal Obstruction, Rhinitis, Allergic

What participants receive

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

  • Auricular acupressureOther

    Auricular acupressure therapy will be performed once a week for 4 weeks using Vaccaria seeds, which is an herb in traditional medicine. The acupoints on the ear that will be treated with auricular acupressure therapy are Shenmen (TF4), Internal nose (TG4), Lung (CO14), Wind stream (SF1,2i), Adrenal gland (TG2p). These acupoints are believed to be effective in the treatment of allergic rhinitis. The patches will be kept on the auricle for one week.

  • Sham acupressureOther

    Sham acupressure therapy will be performed once a week for 4 weeks using Vaccaria seeds. The acupoints that will be treated with auricular acupressure therapy are Helix 2 (HX10), Shoulder (SF4), Clavicle (SF6), Anus (HX5) and Tooth (LO1). These acupoints are not used to treat allergic immune-related problems or respiratory diseases. The patches will be kept on the auricle for one week.

  • Standard treatmentOther

    Standard treatment, continuously administered over the 4-week intervention period, involves standard doses of fluticasone propionate nasal spray as needed, and lifestyle modifications.

Study groups in NCT06323304
Study groupRoleWhat they receive
Auricular acupressure + fluticasone propionate nasal sprayExperimentalAuricular acupressure therapy (AAT) once a week on the left ear for a total of four weeks (4 sessions). Fluticasone propionate nasal spray will be used whenever symptoms occur.
Receives: Other: Auricular acupressure; Other: Standard treatment
Sham acupressure + fluticasone propionate nasal spraySham comparatorSham acupressure therapy (SAT) once a week on the left ear for a total of four weeks (4 sessions). Fluticasone propionate nasal spray will be used whenever symptoms occur.
Receives: Other: Sham acupressure; Other: Standard treatment

What is being measured

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

  1. The change of nasal and non nasal symptom scores

    Symptom scores will be assessed based on a visual analogue scale (VAS). It usually consists of a 100 mm line anchored at each end by descriptors.

    Measured: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)

Secondary outcomes (3)

  1. The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score

    The RQLQ consists of 28 items. Participants will be requested to express their agreement using a Likert-type scale that ranges from 0=not troubled to 6=extremely troubled. The RQLQ score is calculated by taking the sum of the scores for all question. The higher the score, the more impaired the quality of life.

    Measured: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)

  2. The change of relief medication usage

    The number of times fluticasone propionate nasal spray is used is recorded each week by asking the patient.

    Measured: Assessments were conducted after each intervention week throughout the four weeks (Week 1, Week 2, Week 3, Week 4)

  3. Proportion of intervention-related adverse events

    While auricular acupressure is generally considered safe, some patients may experience minor side effects at the application site. These can include temporary pain, discomfort, itching, redness, or minor inflammation. Rarely, more serious complications like chondritis, dizziness, nausea, or allergic reactions may occur. The study will closely monitor and document any unexpected adverse events associated with the procedure.

    Measured: Up to four weeks

Timeline

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

  1. First posted21 Mar 2024
  2. Study start13 Mar 2024
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2024

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06323304
Sponsor's protocol ID
701/HDDD-DHYD
Status last verified
Oct 2024
First submitted
14 Mar 2024
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bousquet JJ, Schunemann HJ, Togias A, Erhola M, Hellings PW, Zuberbier T, Agache I, Ansotegui IJ, Anto JM, Bachert C, Becker S, Bedolla-Barajas M, Bewick M, Bosnic-Anticevich S, Bosse I, Boulet LP, Bourrez JM, Brusselle G, Chavannes N, Costa E, Cruz AA, Czarlewski W, Fokkens WJ, Fonseca JA, Gaga M, Haahtela T, Illario M, Klimek L, Kuna P, Kvedariene V, Le LTT, Larenas-Linnemann D, Laune D, Lourenco OM, Menditto E, Mullol J, Okamoto Y, Papadopoulos N, Pham-Thi N, Picard R, Pinnock H, Roche N, Roller-Wirnsberger RE, Rolland C, Samolinski B, Sheikh A, Toppila-Salmi S, Tsiligianni I, Valiulis A, Valovirta E, Vasankari T, Ventura MT, Walker S, Williams S, Akdis CA, Annesi-Maesano I, Arnavielhe S, Basagana X, Bateman E, Bedbrook A, Bennoor KS, Benveniste S, Bergmann KC, Bialek S, Billo N, Bindslev-Jensen C, Bjermer L, Blain H, Bonini M, Bonniaud P, Bouchard J, Briedis V, Brightling CE, Brozek J, Buhl R, Buonaiuto R, Canonica GW, Cardona V, Carriazo AM, Carr W, Cartier C, Casale T, Cecchi L, Cepeda Sarabia AM, Chkhartishvili E, Chu DK, Cingi C, Colgan E, de Sousa JC, Courbis AL, Custovic A, Cvetkosvki B, D'Amato G, da Silva J, Dantas C, Dokic D, Dauvilliers Y, Dedeu A, De Feo G, Devillier P, Di Capua S, Dykewickz M, Dubakiene R, Ebisawa M, El-Gamal Y, Eller E, Emuzyte R, Farrell J, Fink-Wagner A, Fiocchi A, Fontaine JF, Gemicioglu B, Schmid-Grendelmeir P, Gamkrelidze A, Garcia-Aymerich J, Gomez M, Gonzalez Diaz S, Gotua M, Guldemond NA, Guzman MA, Hajjam J, O'B Hourihane J, Humbert M, Iaccarino G, Ierodiakonou D, Illario M, Ivancevich JC, Joos G, Jung KS, Jutel M, Kaidashev I, Kalayci O, Kardas P, Keil T, Khaitov M, Khaltaev N, Kleine-Tebbe J, Kowalski ML, Kritikos V, Kull I, Leonardini L, Lieberman P, Lipworth B, Lodrup Carlsen KC, Loureiro CC, Louis R, Mair A, Marien G, Mahboub B, Malva J, Manning P, De Manuel Keenoy E, Marshall GD, Masjedi MR, Maspero JF, Mathieu-Dupas E, Matricardi PM, Melen E, Melo-Gomes E, Meltzer EO, Menditto E, Mercier J, Miculinic N, Mihaltan F, Milenkovic B, Moda G, Mogica-Martinez MD, Mohammad Y, Montefort S, Monti R, Morais-Almeida M, Mosges R, Munter L, Muraro A, Murray R, Naclerio R, Napoli L, Namazova-Baranova L, Neffen H, Nekam K, Neou A, Novellino E, Nyembue D, O'Hehir R, Ohta K, Okubo K, Onorato G, Ouedraogo S, Pali-Scholl I, Palkonen S, Panzner P, Park HS, Pepin JL, Pereira AM, Pfaar O, Paulino E, Phillips J, Picard R, Plavec D, Popov TA, Portejoie F, Price D, Prokopakis EP, Pugin B, Raciborski F, Rajabian-Soderlund R, Reitsma S, Rodo X, Romano A, Rosario N, Rottem M, Ryan D, Salimaki J, Sanchez-Borges MM, Sisul JC, Sole D, Somekh D, Sooronbaev T, Sova M, Spranger O, Stellato C, Stelmach R, Suppli Ulrik C, Thibaudon M, To T, Todo-Bom A, Tomazic PV, Valero AA, Valenta R, Valentin-Rostan M, van der Kleij R, Vandenplas O, Vezzani G, Viart F, Viegi G, Wallace D, Wagenmann M, Wang Y, Waserman S, Wickman M, Williams DM, Wong G, Wroczynski P, Yiallouros PK, Yorgancioglu A, Yusuf OM, Zar HJ, Zeng S, Zernotti M, Zhang L, Zhong NS, Zidarn M; ARIA Study Group; MASK Study Group. Next-generation ARIA care pathways for rhinitis and asthma: a model for multimorbid chronic diseases. Clin Transl Allergy. 2019 Sep 9;9:44. doi: 10.1186/s13601-019-0279-2. eCollection 2019.

    PubMed 31516692

  • Dykewicz MS, Wallace DV, Amrol DJ, Baroody FM, Bernstein JA, Craig TJ, Dinakar C, Ellis AK, Finegold I, Golden DBK, Greenhawt MJ, Hagan JB, Horner CC, Khan DA, Lang DM, Larenas-Linnemann DES, Lieberman JA, Meltzer EO, Oppenheimer JJ, Rank MA, Shaker MS, Shaw JL, Steven GC, Stukus DR, Wang J; Chief Editor(s):; Dykewicz MS, Wallace DV; Joint Task Force on Practice Parameters:; Dinakar C, Ellis AK, Golden DBK, Greenhawt MJ, Horner CC, Khan DA, Lang DM, Lieberman JA, Oppenheimer JJ, Rank MA, Shaker MS, Stukus DR, Wang J; Workgroup Contributors:; Dykewicz MS, Wallace DV, Amrol DJ, Baroody FM, Bernstein JA, Craig TJ, Finegold I, Hagan JB, Larenas-Linnemann DES, Meltzer EO, Shaw JL, Steven GC. Rhinitis 2020: A practice parameter update. J Allergy Clin Immunol. 2020 Oct;146(4):721-767. doi: 10.1016/j.jaci.2020.07.007. Epub 2020 Jul 22.

    PubMed 32707227

  • Nogier R. History of Auriculotherapy: Additional Information and New Developments. Med Acupunct. 2021 Dec 1;33(6):410-419. doi: 10.1089/acu.2021.0075. Epub 2021 Dec 16.

    PubMed 34976274

  • Rao YQ, Han NY. [Therapeutic effect of acupuncture on allergic rhinitis and its effects on immunologic function]. Zhongguo Zhen Jiu. 2006 Aug;26(8):557-60. Chinese.

    PubMed 16941973

  • Zhong J, Liu S, Lai D, Lu T, Shen Y, Gong Q, Li P, Zhang Q. Ear Acupressure for Allergic Rhinitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2021 May 3;2021:6699749. doi: 10.1155/2021/6699749. eCollection 2021.

    PubMed 34007299

  • Zhang CS, Xia J, Zhang AL, Yang AW, Thien F, Li Y, Wu D, Cai J, DaCosta C, Xue CC. Ear acupressure for perennial allergic rhinitis: A multicenter randomized controlled trial. Am J Rhinol Allergy. 2014 Jul-Aug;28(4):e152-7. doi: 10.2500/ajra.2014.28.4081.

    PubMed 25197908

  • Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr;236(4):588-611. doi: 10.1111/joa.13122. Epub 2019 Nov 19.

    PubMed 31742681

  • Hou PW, Hsu HC, Lin YW, Tang NY, Cheng CY, Hsieh CL. The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. Evid Based Complement Alternat Med. 2015;2015:495684. doi: 10.1155/2015/495684. Epub 2015 Dec 28.

    PubMed 26823672

  • Feng L, Lin L, Wang S, Zhao X, Dai Q, Wang L, Yang Y, Xu L, Liu Y, An L, Shen C. Clinical practice guidelines for the treatment of allergic rhinitis in children with traditional Chinese medicine. Anat Rec (Hoboken). 2021 Nov;304(11):2592-2604. doi: 10.1002/ar.24718. Epub 2021 Jul 29.

    PubMed 34323398

  • Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10.

    PubMed 25435890

  • Le NC, Bui MP, Trinh DT. Evaluating efficacy and safety of auricular acupressure in treating allergic rhinitis: A randomized controlled trial. Integr Med Res. 2025 Sep;14(3):101177. doi: 10.1016/j.imr.2025.101177. Epub 2025 Jun 9.

    PubMed 40677297

Questions about this trial

What is this clinical trial studying?

A study testing Auricular acupressure and Standard treatment in people with Itching and Runny Nose, 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 7 inclusion and 5 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 29 Oct 2024. 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. Some participants in this study may receive a placebo. 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?

The change of nasal and non nasal symptom scores (time frame: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)). 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 NCT06323304, which also lists 11 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 29 Oct 2024.

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