Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06756243

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrogen Ion Water（Shan Shang Water）

Other

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

Drug

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

Primary outcomes

  1. Total Nasal Symptom Score (TNSS)

    Time frame: 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.

  2. Total Non-Nasal Symptom Score (TNNSS)

    Time frame: 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.

  3. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

    Time frame: 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.

  4. the serum level of total IgE

    Time frame: 24 weeks

    Total IgE levels are often elevated in allergic conditions and can reflect the overall atopic status of the patient.

  5. the serum level of total IgG

    Time frame: 24 weeks

    Total IgG levels provide insight into the general immunoglobulin status and can be relevant in assessing immune responses.

  6. the serum level of total IgA

    Time frame: 24 weeks

    Total IgA levels are measured to evaluate mucosal immunity, as IgA plays a crucial role in mucosal defense mechanisms.

  7. the serum level of specific IgE

    Time frame: 24 weeks

    These antibodies are measured to identify sensitization to particular allergens, aiding in the diagnosis and management of allergic diseases.

  8. the serum level of specific IgG4

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huiying Wang, Doctor

CONTACT

[email protected]

86(0571)-87783627

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

The Observation of the Effects of Hydrogen Ion Water (Shan Shang Water) on Clinical Symptoms and Immune Markers in Allergic Rhinitis.

Acronym: SSWAR

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 1, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.