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Allergic Rhinitis (AR)NCT07537439

Evaluation of the Adjunctive Effects of Moxibustion in the Treatment of Cold-Syndrome Allergic Rhinitis

A study testing Mild moxibustion and Fluticasone propionate 100 mcg in people with Allergic Rhinitis (AR), run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Allergic rhinitis (AR) is an inflammatory disease of the nasal mucosa characterized by one or more of the following symptoms: nasal obstruction, rhinorrhea, sneezing, and nasal itching. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Allergic Rhinitis (AR)
What is being tested?
Mild moxibustion and Fluticasone propionate 100 mcg
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteVietnam
Study dates
1 Mar 2026to 1 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Adults aged 18 to 60 years.
  • Diagnosed with allergic rhinitis according to ARIA guidelines.
  • Presence of typical nasal symptoms such as sneezing, rhinorrhea, nasal obstruction, or nasal itching.
  • Classified as cold-related syndrome according to traditional medicine assessment.
  • Indicated for treatment with intranasal corticosteroids.
  • Willing and able to provide written informed consent.

Who cannot join

  • Pregnant or breastfeeding individuals.
  • Severe nasal structural abnormalities or nasal polyps.
  • History of asthma or other significant chronic respiratory diseases.
  • Known allergy or intolerance to moxibustion smoke or study medications.
  • Severe comorbid medical conditions that may interfere with study participation.
  • Inability to comply with study procedures.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site
  • Ho Chi Minh City Orthopedics and Rehabilitation Hospital

    Ho Chi Minh City, Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: Evaluation Of The Adjunctive Effects Of Moxibustion In The Treatment Of Cold-Syndrome Allergic Rhinitis

Allergic rhinitis (AR) is an inflammatory disease of the nasal mucosa characterized by one or more of the following symptoms: nasal obstruction, rhinorrhea, sneezing, and nasal itching. It is an IgE-mediated immune disorder that typically occurs after exposure to allergens such as pollen, house dust mites, and animal dander. The reported prevalence of rhinitis in adults ranges widely from 1% to over 60%, largely depending on diagnostic definitions and geographic regions. Allergic rhinitis is estimated to affect approximately 10% to 30% of the global population and imposes a substantial burden on sleep quality, quality of life, cognitive function, and work productivity.

Due to its chronic course, frequent recurrence, and complex pathophysiology, allergic rhinitis not only adversely affects patients' physical and mental health and overall quality of life but also results in significant socioeconomic burden. Current standard management strategies include allergen avoidance and pharmacological treatments such as oral and intranasal antihistamines, leukotriene receptor antagonists, and intranasal glucocorticoids. However, despite stepwise treatment approaches, a considerable proportion of patients continue to experience persistent symptoms and impaired quality of life, and may suffer from medication-related adverse effects, including drowsiness, dryness of the nasal or ocular mucosa, and nasal irritation.

Read more

Allergen-specific immunotherapy is currently regarded as the only disease-modifying treatment for allergic rhinitis. Nevertheless, its long treatment duration, high cost, requirement for medical supervision, and variable patient response substantially limit accessibility and long-term adherence, particularly in low- and middle-income countries. In this context, there is an increasing need to identify adjunctive therapeutic approaches that are safe, effective, cost-efficient, and culturally acceptable.

Traditional medicine has been widely applied in the management of allergic rhinitis in many countries, including Vietnam. Therapeutic modalities such as acupuncture, moxibustion, thread embedding therapy, and herbal medicine have been reported to alleviate symptoms, reduce recurrence rates, improve quality of life, and decrease reliance on pharmacological treatments.

Moxibustion is a traditional therapeutic technique that applies heat generated by burning moxa sticks or moxa cones to specific acupuncture points, with the aim of regulating Qi and blood, strengthening vital energy, and enhancing the body's resistance to disease. This method is generally considered safe, easy to administer, low-cost, and suitable for implementation in community settings and primary health-care facilities. Several clinical studies worldwide have demonstrated that moxibustion can significantly improve symptoms of allergic rhinitis with a low incidence of adverse effects.

However, high-quality scientific evidence regarding the efficacy and safety of moxibustion in the treatment of allergic rhinitis remains limited. In particular, there is a lack of well-designed and standardized randomized controlled trials. In Vietnam, although moxibustion is commonly used in traditional medicine practice, no clinical studies to date have systematically evaluated its effectiveness and safety in patients with allergic rhinitis. This gap in evidence highlights the need for rigorously designed clinical studies to strengthen the scientific basis, standardize treatment protocols, support the integration of moxibustion into clinical practice, and guide the development of integrative treatment models combining conventional medicine and traditional medicine in the management of allergic rhinitis.

Based on these considerations, the present study is conducted to evaluate the efficacy and safety of moxibustion in the treatment of allergic rhinitis, with the aim of providing additional clinical evidence, improving treatment quality, and optimizing disease management for patients.

Read the detailed description

Allergic rhinitis is a chronic inflammatory condition of the nasal mucosa that is associated with symptoms such as nasal congestion, rhinorrhea, sneezing, and nasal itching. The condition has a significant impact on daily functioning, sleep quality, and overall quality of life. Although conventional medical treatments are effective in many cases, a proportion of patients experience persistent symptoms, incomplete symptom control, or adverse effects related to long-term medication use. These challenges have prompted increasing interest in complementary and integrative treatment approaches.

Moxibustion is a traditional therapeutic technique that delivers thermal stimulation to specific acupuncture points through the burning of moxa. Mild moxibustion, in particular, produces a warming effect without causing tissue damage and is commonly used in traditional medicine for conditions associated with cold-related syndromes. In traditional medicine theory, allergic rhinitis is often associated with insufficiency of defensive energy and dysfunction of internal organ systems, particularly those responsible for respiratory and fluid regulation. Mild moxibustion is traditionally applied to support physiological balance by warming meridians, strengthening vital energy, and enhancing the body's adaptive capacity.

From a biomedical perspective, previous studies suggest that moxibustion may exert therapeutic effects through multiple mechanisms, including local thermal stimulation, infrared radiation, and the bioactive components released during moxa combustion. These effects may influence local blood circulation, neuroimmune regulation, and inflammatory responses. Clinical studies and systematic reviews have reported improvements in nasal symptoms and quality of life in patients with allergic rhinitis treated with moxibustion, with relatively few and mild adverse effects. However, many existing studies are limited by small sample sizes, heterogeneous treatment protocols, and methodological limitations, underscoring the need for rigorously designed clinical trials.

This study is designed to evaluate the efficacy and safety of mild moxibustion as an adjunctive therapy in patients with cold-syndrome allergic rhinitis. The study adopts an interventional randomized controlled design to compare standard conventional medical treatment alone with standard treatment combined with mild moxibustion. By focusing on adjunctive use, the study aims to assess whether moxibustion can enhance clinical outcomes without replacing established medical care.

Participants assigned to the intervention arm will receive mild moxibustion delivered according to a standardized treatment protocol. The intervention will be administered by licensed physicians trained in traditional medicine to ensure consistency and safety. Treatment sessions will be scheduled at regular intervals over a defined treatment period. Participants in both study arms will continue to receive conventional medical care in accordance with current clinical practice guidelines.

Clinical evaluation will focus on changes in nasal symptoms, patient-reported quality of life, and patterns of symptomatic medication use throughout the study period. Safety will be monitored through systematic documentation of adverse events potentially related to either moxibustion or conventional treatment. All adverse events will be assessed for severity and clinical relevance.

The study is conducted in accordance with ethical principles governing research involving human participants. Approval has been obtained from an institutional ethics review board prior to study initiation. All participants will provide written informed consent before enrollment and will retain the right to withdraw from the study at any time without consequences to their routine medical care.

The results of this study are expected to provide clinically relevant evidence regarding the role of mild moxibustion as a complementary therapy for allergic rhinitis. By applying a standardized intervention and rigorous study design, the findings may help clarify the potential benefits and safety profile of moxibustion, support evidence-based integration of traditional and conventional medicine, and inform future clinical practice and research in the management of allergic rhinitis.

Being tested
Mild moxibustion, Fluticasone propionate 100 mcg
Keywords
Allergic Rhinitis, Moxibustion, Mild Moxibustion, Randomized Controlled Trial, Traditional Medicine, Cold Syndrome
Medical subject headings
Rhinitis, Allergic

What participants receive

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

  • Mild moxibustionProcedure or surgery

    Mild moxibustion is administered as an adjunctive therapy using burning moxa sticks applied to predefined acupuncture points according to a standardized protocol

  • Fluticasone propionate 100 mcgDrug

    Standard conventional medical treatment for allergic rhinitis is provided according to current clinical practice guidelines, including intranasal corticosteroid therapy and lifestyle modification measures such as allergen avoidance and patient education.

Study groups in NCT07537439
Study groupRoleWhat they receive
Moxibustion plus standard treatmentExperimentalParticipants in this arm receive standard conventional medical treatment for allergic rhinitis combined with adjunctive mild moxibustion. Mild moxibustion is administered according to a standardized protocol by licensed traditional medicine physicians, in addition to usual care provided under current clinical practice guidelines
Receives: Procedure: Mild moxibustion; Drug: Fluticasone propionate 100 mcg
Standard treatment aloneActive comparatorParticipants in this arm receive standard conventional medical treatment for allergic rhinitis according to current clinical practice guidelines, without adjunctive moxibustion
Receives: Drug: Fluticasone propionate 100 mcg

What is being measured

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

  1. Change in Total Nasal Symptom Score (TNSS)

    Change in Total Nasal Symptom Score (TNSS). TNSS evaluates four nasal symptoms: sneezing, rhinorrhea, nasal obstruction, and nasal itching. Scores range from 0 to 12, with higher scores indicating more severe symptoms and a worse outcome.

    Measured: Baseline, Week 2, and Week 4

Secondary outcomes (3)
  1. Change in Visual Analogue Scale (VAS) score for nasal symptoms

    Change in patient-reported severity of nasal symptoms measured using a 10-cm Visual Analogue Scale (VAS). Scores range from 0 to 10, where 0 indicates no symptoms and 10 indicates the most severe symptoms imaginable. Higher scores indicate worse symptom severity.

    Measured: Baseline, Week 1, Week 2, Week 3, and Week 4

  2. Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score

    Change in disease-specific quality of life assessed using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). RQLQ scores range from 0 to 6, with higher scores indicating greater impairment in quality of life and a worse outcome.

    Measured: Baseline, Week 2, and Week 4

  3. Use of symptomatic medication for allergic rhinitis

    Change in the use of symptomatic medication for allergic rhinitis during the study period.

    Measured: Weekly during the 4-week treatment period

Timeline

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

  1. First posted17 Apr 2026
  2. Study start1 Mar 2026
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

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
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07537439
Sponsor's protocol ID
251093
Status last verified
Apr 2026
First submitted
12 Apr 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mild moxibustion and Fluticasone propionate 100 mcg in people with Allergic Rhinitis (AR), 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 6 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in Total Nasal Symptom Score (TNSS) (time frame: Baseline, Week 2, and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Jul 2026.

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