To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With 3 Increasing Doses of Molecular Hydrogen Supplement.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse effects/symptoms
研究概览
简要总结
The latest international research shows that supplementation of hydrogen molecules as an aid, adjuvant, can speed up the course of the disease. The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different dose exposures for a clinical study in rheumatologic and metabolic patients. Patients will receive a different dosage of hydrogen capsules 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
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 70 with autoimmune or metabolic diseases
- •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 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.
干预措施: Hydrogen (Drug)
结局指标
主要结局
Adverse effects/symptoms
时间窗: up to 28 days
Any adverse effects will be codified according the the NCI CTCAE v5.0
次要结局
- Change in physiological parameter (Urine Routine)(Change from Baseline Urine Routine at Day 28)
- Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions)(Change from Baseline BFI-T at Day 28)
- Change in physiological parameter (Blood Routine)(Change from Baseline Blood Routine at Day 28)
- Control status scale for diabetics (CSSD70) (First part: 11 questions)(Change from Baseline CSSD70 at Day 28)
