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临床试验/NCT05116215
NCT05116215Unknown1 期

To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement

HoHo Biotech1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年8月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
27
试验地点
1
主要终点
Disease Activity Score, DAS 28

研究概览

简要总结

The supplementation of hydrogen molecules as an aid, adjuvant, may speed up recovering the course of the disease. The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different formula and dose exposures for a clinical study in rheumatologic patients. Patients will receive a different dosage of either hydrogen capsules, hydrogen gas or hydrogen-rich water with their conventional treatment for a month. Investigators will test for any changes in haematologic, urine analysis and health status during and following the exposure period.

详细描述

Hydrogen supplement has been shown to have significant removing effects on free radicals. International clinical trials have shown promise that hydrogen molecules may reduce chronic inflammatory and then speed up recovering the course of the disease.

The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different formula and dose exposures for a clinical study in rheumatologic patients.

Study design: 27 rheumatologic patients will be recruited from the Tri-Service General Hospital for this study. Participants will be screened by doctors for their eligibility and undergo a series of tests (questionnaires and examinations). Consenting participants will then be allocated into 3 groups by different dosage forms (Gas, n=9; Water, n=9; Capsules, n=9). Participants in the gas group will then undergo exposure to 2% H2 in medical air via a high flow nasal cannula for either 1 (n=3), 2 (n=3) or 4 (n=3) hours every day for one month. Participants in capsule group will receive 1 (n=3), 3 (n=3) or 6 (n=3) capsules every day for one month. Participants in the water group will be suggested to drink 1 L hydrogen-rich water every day for one month. Participants will be examined their regular haematology, urine and health status before and after the intervention.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20 to 80
  • Able to compliant with the protocol
  • Able to return to the hospital regularly

排除标准

  • Pregnancy
  • Expected pregnancy

研究组 & 干预措施

Hydrogen water

Experimental

Participants in the water group will be suggested to drink 1 L hydrogen-rich water every day for one month.

干预措施: Hydrogen (Drug)

Hydrogen inhalation

Experimental

Participants in the gas group will then undergo exposure to 2% H2 in medical air via a high flow nasal cannula for either 1 (n=3), 2 (n=3) or 4 (n=3) hours every day for one month.

干预措施: Hydrogen (Drug)

Hydrogen capsules

Experimental

Participants in capsule group will receive either 1 (n=3), 3 (n=3) or 6 (n=3) capsules every day for one month.

干预措施: Hydrogen (Drug)

结局指标

主要结局

Disease Activity Score, DAS 28

时间窗: Change from Baseline DAS 28 at Day 28

A score of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.

Health Assessment Questionnaire Disability Index, HAQ-DI

时间窗: Change from Baseline HAQ-DI at Day 28

Questionnaire

Change in Blood Routine

时间窗: Change from Baseline Blood Routine at Day 28

Numerical change in Blood Routine

Change in Urine Routine

时间窗: Change from Baseline Urine Routine at Day 28

Numerical change in Urine Routine

次要结局

未报告次要终点

研究者

发起方
HoHo Biotech
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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