An interventional study of Hydrogen Ion Water（Shan Shang Water） and Budesonide Nasal Spray therapy in Allergic Rhinitis, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
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.
Control Group:
The control group will drink 1,500-2,000 ml of water daily, following their normal routine.
Visit Schedule:
Participants will visit the clinic every 4 weeks for checkups and tests. Participants will also keep a daily diary to track their symptoms, including sneezing, nasal congestion, runny nose, and any medication use.
Expected Results:
Symptom Improvement:
The investigators will assess the reduction in allergic rhinitis symptoms (sneezing, nasal congestion, runny nose, and itching).
Immune Response:
The investigators will monitor immune markers like IgE levels and eosinophil counts every 3 months.
Conclusion:
This trial will determine if Shan Shang Water can be an effective treatment for allergic rhinitis by reducing symptoms and affecting immune markers. The results will provide valuable insights into its potential use as a non-pharmacological treatment option for allergic rhinitis.
Exclusion Criteria:
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.
Other: Hydrogen Ion Water（Shan Shang Water） · Drug: Budesonide Nasal Spray therapy
Participants in this group maintained a daily water intake of 1500-2000 ml, following their regular hydration habits, without specific restrictions or additional instructions.
Drug: Budesonide Nasal Spray therapy
Hydrogen Ion Water (also known as Hydrogen-Rich Water or Hydrogen Water) refers to water that contains dissolved hydrogen gas (H₂). Hydrogen gas is a powerful antioxidant that is believed to neutralize free radicals in the body, which may help reduce oxidative stress and improve overall health.
Budesonide Nasal Spray: Administered as 2 sprays twice daily (bid).
Total Nasal Symptom Score (TNSS)
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.
Time frame: 24 weeks
Total Non-Nasal Symptom Score (TNNSS)
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.
Time frame: 24 weeks
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
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.
Time frame: 24 weeks
the serum level of total IgE
Total IgE levels are often elevated in allergic conditions and can reflect the overall atopic status of the patient.
Time frame: 24 weeks
the serum level of total IgG
Total IgG levels provide insight into the general immunoglobulin status and can be relevant in assessing immune responses.
Time frame: 24 weeks
the serum level of total IgA
Total IgA levels are measured to evaluate mucosal immunity, as IgA plays a crucial role in mucosal defense mechanisms.
Time frame: 24 weeks
the serum level of specific IgE
These antibodies are measured to identify sensitization to particular allergens, aiding in the diagnosis and management of allergic diseases.
Time frame: 24 weeks
the serum level of specific IgG4
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.
Time frame: 24 weeks
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University