To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With 3 Increasing Doses of Molecular Hydrogen Supplement.

Conditions
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Autoimmune Diseases, Metabolic Disease

Intervention / Treatment
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* Drug: Hydrogen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrogen capsules<br>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. | Drug: Hydrogen<br>* Participants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects/symptoms | Any adverse effects will be codified according the the NCI CTCAE v5.0 | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physiological parameter (Blood Routine) | Numerical change in Blood Routine | Change from Baseline Blood Routine at Day 28 | 
| Change in physiological parameter (Urine Routine) | Numerical change in Urine Routine | Change from Baseline Urine Routine at Day 28 | 
| Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions) | Questionnaire for rheumatologic patients minimum values:0 maximum values:60 Higher scores mean a worse outcome. | Change from Baseline BFI-T at Day 28 | 
| Control status scale for diabetics (CSSD70) (First part: 11 questions) | Questionnaire for metabolic patients minimum values:0 maximum values:22 Higher scores mean a worse outcome. | Change from Baseline CSSD70 at Day 28 |