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

NCT07537439 | Not Yet Recruiting

• 1 other identifier: 251093
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Allergic Rhinitis (AR)

Keywords

Allergic rhinitis; Moxibustion; Mild moxibustion; Traditional medicine; Complementary therapy; Cold syndrome

Outcome Measures

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.

  Baseline and after 2 weeks and 4 weeks of treatment

Secondary Outcomes (3)

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

  Baseline and weekly during the 4-week treatment period

• Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score

  Baseline and after 2 weeks and 4 weeks of treatment

• Use of symptomatic medication for allergic rhinitis

  Weekly during the 4-week treatment period

Other Outcomes (1)

• Adverse events related to moxibustion and conventional treatment

  Throughout the 4-week treatment period

Study Arms (2)

Moxibustion plus standard treatment

EXPERIMENTAL

Participants 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

Procedure: Mild moxibustion; Drug: Fluticasone propionate 100 mcg

Standard treatment alone

ACTIVE COMPARATOR

Participants in this arm receive standard conventional medical treatment for allergic rhinitis according to current clinical practice guidelines, without adjunctive moxibustion

Drug: Fluticasone propionate 100 mcg

Interventions

Mild moxibustion PROCEDURE

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

Moxibustion plus standard treatment

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.

Moxibustion plus standard treatment; Standard treatment alone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician in Traditional Medicine

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04