Evaluation Of The Adjunctive Effects Of Moxibustion In The Treatment Of Cold-Syndrome Allergic Rhinitis
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Enrollment
- 60
- Primary Endpoint
- Change in Total Nasal Symptom Score (TNSS)
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Moxibustion plus standard treatment
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
Intervention: Mild moxibustion (Procedure)
Moxibustion plus standard treatment
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
Intervention: Fluticasone propionate 100 mcg (Drug)
Standard treatment alone
Participants in this arm receive standard conventional medical treatment for allergic rhinitis according to current clinical practice guidelines, without adjunctive moxibustion
Intervention: Fluticasone propionate 100 mcg (Drug)
Outcomes
Primary Outcomes
Change in Total Nasal Symptom Score (TNSS)
Time Frame: Baseline and after 2 weeks and 4 weeks of treatment
Change in the Total Nasal Symptom Score (TNSS), which assesses the severity of core nasal symptoms including sneezing, rhinorrhea, nasal obstruction, and nasal itching.
Secondary Outcomes
- 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)
Investigators
Vi Minh Hai
Resident Physician in Traditional Medicine
University of Medicine and Pharmacy at Ho Chi Minh City