The Use of Hydrogen Ion Water (Shan Shang Water) in the Treatment of Allergic Rhinitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydrogen Ion Water（Shan Shang Water）, Budesonide Nasal Spray therapy.
- Who it may be relevant to
- Registry conditions: Allergic Rhinitis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Observation of the Effects of Hydrogen Ion Water (Shan Shang Water) on Clinical Symptoms and Immune Markers in Allergic Rhinitis.
Overview
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.
Detailed description
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.
Interventions
- Other Hydrogen Ion Water（Shan Shang Water）
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. - Drug Budesonide Nasal Spray therapy
Budesonide Nasal Spray: Administered as 2 sprays twice daily (bid).
Primary outcome measures
- Total Nasal Symptom Score (TNSS) [Time frame: 24 weeks]
- Total Non-Nasal Symptom Score (TNNSS) [Time frame: 24 weeks]
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [Time frame: 24 weeks]
- the serum level of total IgE [Time frame: 24 weeks]
- the serum level of total IgG [Time frame: 24 weeks]
- the serum level of total IgA [Time frame: 24 weeks]
- the serum level of specific IgE [Time frame: 24 weeks]
- the serum level of specific IgG4 [Time frame: 24 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT06756243 · 2024-0508