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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this trial

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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mild moxibustion

    Procedure/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 mcg

    Drug

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Moxibustion plus standard treatmentExperimental treatment 2 interventions
Group B: Standard treatment aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Total Nasal Symptom Score (TNSS)

Change in the Total Nasal Symptom Score (TNSS), which assesses the severity of core nasal symptoms including sneezing, rhinorrhea, nasal obstruction, and nasal itching.

Time frame
Baseline and after 2 weeks and 4 weeks of treatment

Secondary outcomes

1

Change in Visual Analogue Scale (VAS) score for nasal symptoms

Change in patient-reported severity of nasal symptoms measured using the Visual Analogue Scale (VAS).

Time frame
Baseline and weekly during the 4-week treatment period
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).

Time frame
Baseline and after 2 weeks and 4 weeks of treatment
3

Use of symptomatic medication for allergic rhinitis

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

Time frame
Weekly during the 4-week treatment period

Other outcomes

1

Adverse events related to moxibustion and conventional treatment

Occurrence of adverse events related to moxibustion or conventional medical treatment during the study period

Time frame
Throughout the 4-week treatment period

Locations

This trial has no locations.

Sponsors and contacts

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