Clinical Research Directory

Lacticaseibacillus Rhamnosus LRa05 for Alleviating Allergic Rhinitis

This clinical trial aims to evaluate the efficacy and safety of Lactobacillus rhamnosus LRa05 in alleviating allergic rhinitis symptoms and its effects on gut microbiota in 70 adults aged 18-60 years. Participants will receive probiotic powder or placebo daily for 4 weeks. Allergic rhinitis symptoms and quality of life will be assessed, while stool and blood samples will be collected to evaluate changes in gut microbiota and immune-related markers.

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. 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.

EFFECT OF AYURVEDA TREATMENT IN ALLERGIC RHINITIS

Background Allergic Rhinitis is a chronic Th2-mediated inflammatory disorder associated with significant disease burden and impaired quality of life. Emerging evidence highlights the role of the gut-immune axis, intestinal permeability, and microbial-metabolic signaling in modulation of allergic immune responses. In , Agni is considered the fundamental regulator of digestion, metabolism, and physiological homeostasis. Disturbance in Agni may contribute to altered gut homeostasis and immune dysregulation. However, the relationship between Agni, gut permeability-associated mechanisms, and Th2-mediated immune response in allergic rhinitis remains insufficiently explored. Aim To evaluate the effect of an Agni-modulating Ayurvedic intervention on Th2-mediated immune response and gut permeability-associated mechanisms in individuals with allergic rhinitis. Objectives The primary objective is to evaluate the effect of an Agni-modulating Ayurvedic intervention on serum immunoglobulin E (IgE) and interleukin-4 (IL-4) levels in allergic rhinitis. Secondary objectives include assessment of gut permeability-associated biomarkers including serum zonulin and lactulose-mannitol test parameters, evaluation of changes in Agni status and clinical symptom severity, and exploration of associations between Agni status, gut permeability-associated biomarkers, and immune response. The study also aims to explore inter-individual variability based on Agni types and Prakriti. Methods This study is designed as a randomized, controlled, assessor-blinded, parallel-group clinical trial with an embedded exploratory mechanistic component. A total of 104 participants aged 18-60 years diagnosed with allergic rhinitis based on standard clinical criteria and positive skin prick test will be recruited and randomized in a 1:1 ratio into intervention and control groups. The intervention group will receive a standardized Agni-modulating Ayurvedic treatment protocol consisting of Deepana-Pachana formulations followed by Amrita Ghritham along with Pathya-Apathya advice, in addition to standard conventional management. The control group will receive standard conventional management. Primary outcome measures include serum IgE, IL-4, serum zonulin, and lactulose-mannitol test parameters. Secondary outcomes include Agni assessment, Total Nasal Symptom Score (TNSS), eosinophil count, and subgroup analysis based on Agni and Prakriti. Expected Outcome The study is expected to provide preliminary evidence regarding the relationship between Agni modulation, gut permeability-associated mechanisms, and Th2-mediated immune response in allergic rhinitis, and may contribute to biomarker-oriented translational and integrative approaches in allergic disease management.

Comparison of Antihistamine and Antileukotriene Add-On Therapy to Intranasal Corticosteroid in Allergic Rhinitis

Allergic rhinitis is a very common condition that can cause symptoms such as sneezing, a runny nose, nasal blockage, and itching in the nose. These symptoms can interfere with sleep, daily activities, and overall quality of life. Although several medicines are available to treat allergic rhinitis, it is not always clear which combination of treatments works best for patients in everyday clinical practice. The purpose of this study is to compare two commonly used treatment combinations for allergic rhinitis in adults. One group of participants will receive an intranasal corticosteroid along with an oral antihistamine. The other group will receive an intranasal corticosteroid along with an oral antileukotriene. Both treatment approaches aim to reduce inflammation and improve symptoms, but they act through different pathways in the body. This study is designed as a randomized controlled trial. Participants who meet the eligibility criteria will be assigned by chance to one of the two treatment groups. This method helps ensure that the comparison between treatments is fair and unbiased. The main goal of the study is to find out whether one treatment combination provides better relief of nasal symptoms than the other, or if both treatments are equally effective. To assess this, participants' symptoms will be recorded using a structured symptom scoring system at the start of the study and during follow-up visits. Participants will be evaluated at baseline and at scheduled follow-up visits. Changes in their symptoms over time will be carefully monitored and compared between the two groups. The results of this study may help doctors choose the most effective treatment approach for adults with allergic rhinitis and support better evidence-based care. This study has been reviewed and approved by the institutional ethical review committee. Participation in the study is voluntary, and informed consent will be obtained from all participants before enrollment.

Effect of Combined Probiotics and Vitamin D on Symptoms of Allergic Rhinitis

The goal of this clinical trial is to learn if taking probiotics, vitamin D, or both together can help lower symptoms of allergic rhinitis (AR) and improve quality of life in adults. Allergic rhinitis is a condition that causes sneezing, nasal congestion, and itchy or watery eyes. The main questions this study aims to answer are: • Do these supplements improve the quality of life for people with AR? Researchers will compare four groups: * People taking probiotics and vitamin D * People receiving standard treatment only (control group) Participants will: * Take a probiotic capsule daily and/or a vitamin D tablet (based on blood levels) for 12 weeks * Continue standard allergic rhinitis treatment (like antihistamines or nasal sprays) * Visit the clinic for checkups and lab tests * Complete surveys about their symptoms and quality of life This study will help researchers understand if adding probiotics and/or vitamin D to standard care can help people with allergic rhinitis feel better.