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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Total Nasal Symptom Score (TNSS) [Срок оценки: 24 weeks]
• Total Non-Nasal Symptom Score (TNNSS) [Срок оценки: 24 weeks]
• Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [Срок оценки: 24 weeks]
• the serum level of total IgE [Срок оценки: 24 weeks]
• the serum level of total IgG [Срок оценки: 24 weeks]
• the serum level of total IgA [Срок оценки: 24 weeks]
• the serum level of specific IgE [Срок оценки: 24 weeks]
• the serum level of specific IgG4 [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT06756243 · 2024-0508

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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