To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.
To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With 3 Increasing Doses of Molecular Hydrogen Supplement.
研究概览
详细说明
According to the current literature, there is a lack of specific drugs for chronic inflammatory symptoms which develop from many refractory diseases with complicated clinical features. Hydrogen supplement has been shown to have significant removal effects on free radicals and reduce chronic inflammation. With these benefits, molecular hydrogen may have the ability to speed up the recovering the disease.
The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in the different doses of hydrogen capsules for a clinical study in rheumatologic and metabolic patients.
Study design: 15 rheumatologic patients and 15 metabolic patients will be recruited from the Min-Sheng 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 (Low, n=5; Medium, n=5; High, n=5). Participants will receive 1 (Low), 3 (Medium) or 6 (High) capsules every day for one month. Participants will be examined their regular haematology, urine and health status before and after the intervention.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：Kuang-Yih Wang, M.D.
- 电话号码：+886 920757313
- 邮箱：bbban1024@gmail.com
学习地点
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Taoyuan、台湾
- 招聘中
- Min-Sheng Gereral hospital
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接触：
- Wen-Wen Chen
- 电话号码：5506 03 479 4151
- 邮箱：N002737@e-ms.com.tw
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首席研究员：
- Min-Chung Shen, M.D.
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首席研究员：
- Szu-Han Chiu, M.D.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 20 to 70 with autoimmune or metabolic diseases
- Able to compliant with the protocol
- Able to return to the hospital regularly
Exclusion Criteria:
- Pregnancy
- Expected pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Hydrogen capsules
Participants will be allocated by doctors and receive either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.
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Participants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Adverse effects/symptoms
大体时间：up to 28 days
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Any adverse effects will be codified according the the NCI CTCAE v5.0
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up to 28 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in physiological parameter (Blood Routine)
大体时间：Change from Baseline Blood Routine at Day 28
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Numerical change in Blood Routine
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Change from Baseline Blood Routine at Day 28
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Change in physiological parameter (Urine Routine)
大体时间：Change from Baseline Urine Routine at Day 28
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Numerical change in Urine Routine
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Change from Baseline Urine Routine at Day 28
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Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions)
大体时间：Change from Baseline BFI-T at Day 28
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Questionnaire for rheumatologic patients minimum values:0 maximum values:60 Higher scores mean a worse outcome.
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Change from Baseline BFI-T at Day 28
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Control status scale for diabetics (CSSD70) (First part: 11 questions)
大体时间：Change from Baseline CSSD70 at Day 28
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Questionnaire for metabolic patients minimum values:0 maximum values:22 Higher scores mean a worse outcome.
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Change from Baseline CSSD70 at Day 28
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.