Clinical trial NCT06756243: The Use of Hydrogen Ion Water (Shan Shang Water) in the Treatment of Allergic Rhinitis
Official title: The Observation of the Effects of Hydrogen Ion Water (Shan Shang Water) on Clinical Symptoms and Immune Markers in Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis
hydrogen ion water
Clinical Symptoms
immune markers
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Controlled, Single-Center, Prospective, Open-Label Study
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Total Nasal Symptom Score (TNSS)
timeFrame: 24 weeks
measure: Total Non-Nasal Symptom Score (TNNSS)
timeFrame: 24 weeks
measure: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
timeFrame: 24 weeks
measure: the serum level of total IgE
timeFrame: 24 weeks
measure: the serum level of total IgG
timeFrame: 24 weeks
measure: the serum level of total IgA
timeFrame: 24 weeks
measure: the serum level of specific IgE
timeFrame: 24 weeks
measure: the serum level of specific IgG4
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Huiying Wang
role: STUDY_DIRECTOR
References: