NCT06907680已完成2 期
A Randomized Placebo-controlled Crossover Trial Assessing the Efficacy and Safety of M-Gard Particulate EW in the Treatment of Seasonal Allergic Rhinitis
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Relief of symptoms of allergic rhinitis
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy and safety of M-Gard supplementation for alleviating the symptoms of allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-65 years.
- •Generally healthy
- •Individuals with a history of recurrent seasonal allergic rhinitis
- •Positive RAST test for grass allergy
- •BMI 18-35kg/m2
- •Able to provide informed consent
- •Agree not to change current diet and/or exercise routine during entire enrolment period
- •Agree to not participate in another clinical trial during the study period
排除标准
- •Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, neurological disorders such as multiple sclerosis.
- •Unstable illness e.g., diabetes and thyroid gland dysfunction.
- •Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
- •Individuals with symptomatic perennial allergic rhinitis, non-allergic rhinitis, chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
- •Participants with cognitive damage.
- •Acute illness experienced in the past 1 month.
- •Active smokers and/or nicotine or drug abuse.
- •Allergic to any of the ingredients in the active or placebo formula.
- •Chronic past and/or current alcohol use (>21 alcoholic drinks per week)
- •Attempting to conceive, pregnant or lactating women
- •Use of medications that would affect the immune and/or the inflammatory response e.g. immunotherapy, antihistamines (daily use), corticosteroids, mast cell stabilizers, leukotriene modifiers, and decongestants.
- •Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin; tricyclic antidepressants; Clonidine and other central acting alpha-2-agonists.
- •Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
研究组 & 干预措施
M-Gard
Experimental
One capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days.
干预措施: M-Gard (Dietary Supplement)
Placebo
Placebo Comparator
One capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days.
干预措施: Placebo (Other)
结局指标
主要结局
Relief of symptoms of allergic rhinitis
时间窗: Day 0 to Day 43
Relief of symptoms of allergic rhinitis, as measured by: Total and individual allergic rhinitis symptom severity as measured by a visual analogue scale (VAS) of nasal congestion, sneezing, itchy nose, runny nose and watery eyes. These symptoms will be rated on a scale of 0 to 10 where 0 is "not troublesome at all" and 10 is "very troublesome".
次要结局
- Reflective Total Nasal Symptom Scores (rTNSS)(Day 0 to Day 43)
- Reflective Total Ocular Symptom Scores (rTOSS)(Day 0 to Day 43)
- Rhinitis Control Scoring System (RCSS)(Day 0 to Day 43)
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).(Day 0 to Day 43)
- Peak Nasal Inspiratory Flow (PNIF)(Day 0 to Day 43)
- Onset of action of treatment(Day 12 and Day 41)
- Pathology markers(Day 0 to Day 41)
- Use of rescue /concomitant medications(Day 0 to Day 43)
- Safety - Adverse events(Day 0 to Day 43)
- Safety - Vital Signs (Blood Pressure)(Day 0 to Day 41)
- Safety - Vital Signs (Heart Rate)(Day 0 to Day 41)
- Safety - Vital Signs (O2 saturation)(Day 0 to Day 41)
- Safety - Vital Signs (temperature)(Day 0 to Day 41)
- Safety - Safety Markers (FBC)(Day 0 to Day 41)
- Safety - Safety Markers (E/LFT)(Day 0 to Day 41)
研究者
研究点 (1)
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