The Observation of the Effects of Hydrogen Ion Water (Shan Shang Water) on Clinical Symptoms and Immune Markers in Allergic Rhinitis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total Non-Nasal Symptom Score (TNNSS)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether Shan Shang Water (hydrogen ion water) can help treat allergic rhinitis in adults and affect immune markers.
Does Shan Shang Water reduce allergic rhinitis symptoms? What changes occur in immune markers when using Shan Shang Water? Researchers will compare Shan Shang Water to a placebo (an inactive substance) to see if it effectively treats allergic rhinitis.
Participants will:
Take Shan Shang Water or a placebo every day for 24 weeks. Visit the clinic every four weeks for checkups and tests. Record symptoms in a diary, noting things like sneezing, nasal congestion, and any use of medication.
详细描述
The goal of this clinical trial is to evaluate whether Shan Shang Water (hydrogen ion water) can help treat allergic rhinitis in adults and affect immune markers. The main questions the study aims to answer are:
Does Shan Shang Water reduce allergic rhinitis symptoms? What changes occur in immune markers when using Shan Shang Water? Researchers will compare Shan Shang Water to a placebo (an inactive substance) to see if it effectively treats allergic rhinitis.
Participants will:
Take Shan Shang Water or a placebo every day for 24 weeks. Dosage: 660 ml of Shan Shang Water (or placebo) three times a day-morning, noon, and evening.
Drink 30 minutes before meals or when thirsty. Avoid drinking 30 minutes before or after meals and before or after brushing teeth with toothpaste.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermittent or persistent recurrent bouts of sneezing, watery nose, itchy and stuffy nose may be accompanied by eye symptoms including itchy, watery eyes, red and burning eyes, with or without wheezing, coughing, shortness of breath and chest tightness shape.
- •The symptoms are more severe or severe, and have a significant impact on quality of life.
排除标准
- •Pregnant women and parturients.
- •Patients with liver, kidney and heart disease.
- •Patients with past or current tumors.
- •Specific immunotherapy, biologics, or small molecule drug therapy is planned or initiated.
研究组 & 干预措施
Shan Shang Water Group
Participants in this group consumed 660 ml of Shan Shang Water three times daily-morning, noon, and evening-30 minutes before meals or whenever thirsty. They were advised to avoid using toothpaste within 30 minutes before and after drinking the water, as well as within 30 minutes before and after meals. This regimen was followed continuously for 24 weeks.
干预措施: Hydrogen Ion Water（Shan Shang Water） (Other)
Shan Shang Water Group
Participants in this group consumed 660 ml of Shan Shang Water three times daily-morning, noon, and evening-30 minutes before meals or whenever thirsty. They were advised to avoid using toothpaste within 30 minutes before and after drinking the water, as well as within 30 minutes before and after meals. This regimen was followed continuously for 24 weeks.
干预措施: Budesonide Nasal Spray therapy (Drug)
Control Group
Participants in this group maintained a daily water intake of 1500-2000 ml, following their regular hydration habits, without specific restrictions or additional instructions.
干预措施: Budesonide Nasal Spray therapy (Drug)
结局指标
主要结局
Total Non-Nasal Symptom Score (TNNSS)
时间窗: 24 weeks
This score encompasses symptoms beyond the nasal cavity, such as nasal discharge from the pharynx, tearing, nasal or eye itching, and nasal or oral maxillary discomfort. Each symptom is similarly rated on a scale from 0 to 3, providing a comprehensive assessment of allergic manifestations affecting other areas.
Total Nasal Symptom Score (TNSS)
时间窗: 24 weeks
This composite score evaluates the severity of nasal symptoms, including rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is rated on a scale from 0 (no symptoms) to 3 (severe), with the total score ranging from 0 to 12. TNSS is widely utilized to assess the efficacy of treatments targeting nasal symptoms in allergic rhinitis.
the serum level of total IgE
时间窗: 24 weeks
Total IgE levels are often elevated in allergic conditions and can reflect the overall atopic status of the patient.
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
时间窗: 24 weeks
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a validated tool designed to assess the impact of allergic rhinitis on a patient's daily life. It encompasses 28 questions across seven domains: Activity Limitations；Sleep Problems ；Nose Symptoms；Eye Symptoms；Non-Nose/Eye Symptoms；Practical Problems；Emotional Function。Each item is rated on a 7-point scale, ranging from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating a greater negative impact on quality of life. The overall RQLQ score is calculated as the mean of all 28 responses, and individual domain scores are the means of the items within those domains. This scoring system allows clinicians and researchers to quantify the burden of rhinoconjunctivitis on patients and evaluate the effectiveness of therapeutic interventions.
the serum level of total IgG
时间窗: 24 weeks
Total IgG levels provide insight into the general immunoglobulin status and can be relevant in assessing immune responses.
the serum level of total IgA
时间窗: 24 weeks
Total IgA levels are measured to evaluate mucosal immunity, as IgA plays a crucial role in mucosal defense mechanisms.
the serum level of specific IgE
时间窗: 24 weeks
These antibodies are measured to identify sensitization to particular allergens, aiding in the diagnosis and management of allergic diseases.
the serum level of specific IgG4
时间窗: 24 weeks
Elevated levels of allergen-specific IgG4 can be associated with chronic exposure to allergens and may play a role in the modulation of allergic responses.
次要结局
未报告次要终点