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

February 10, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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).
Sham Comparator: 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.
Drug: Budesonide Nasal Spray therapy
Budesonide Nasal Spray: Administered as 2 sprays twice daily (bid).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks
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.
24 weeks
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.
24 weeks
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.
24 weeks
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.
24 weeks
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.
24 weeks
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.
24 weeks
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Director: Huiying Wang, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 25, 2024

First Submitted That Met QC Criteria

December 25, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0508

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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