The Use of Hydrogen Ion Water (Shan Shang Water) in the Treatment of Allergic Rhinitis

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Budesonide Nasal Spray therapy: Budesonide Nasal Spray: Administered as 2 sprays twice daily (bid).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Total Nasal Symptom Score (TNSS) — 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.
• Total Non-Nasal Symptom Score (TNNSS) — 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.
• Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) — 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 IgE — 24 weeks
  Total IgE levels are often elevated in allergic conditions and can reflect the overall atopic status of the patient.
• the serum level of total IgG — 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 — 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 — 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 — 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.

Trial sites (1)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

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