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

NCT06756243 | Not Yet Recruiting

• 1 other identifier: 2024-0508
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis; hydrogen ion water; Clinical Symptoms; immune markers

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  24 weeks

Study Arms (2)

Shan Shang Water Group

EXPERIMENTAL

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

Control Group

SHAM COMPARATOR

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

Interventions

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.

Shan Shang Water Group

Budesonide Nasal Spray therapy DRUG

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

Control Group; Shan Shang Water Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• Huiying Wang

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY DIRECTOR

Central Study Contacts

Huiying Wang, Doctor

CONTACT

86(0571)-87783627; marywang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Controlled, Single-Center, Prospective, Open-Label Study

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 1, 2025
• Study Start: March 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 12, 2025

Record last verified: 2024-12

Locations

CN (1)