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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Autoimmune Diseases

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 80 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: 80 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrogen inhalation<br>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. | Drug: Hydrogen<br>* Hydrogen supplement<br>|
| Experimental: Hydrogen capsules<br>Participants in capsule group will receive either 1 (n=3), 3 (n=3) or 6 (n=3) capsules every day for one month. | Drug: Hydrogen<br>* Hydrogen supplement<br>|
| Experimental: Hydrogen water<br>Participants in the water group will be suggested to drink 1 L hydrogen-rich water every day for one month. | Drug: Hydrogen<br>* Hydrogen supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Routine | Numerical change in Blood Routine | Change from Baseline Blood Routine at Day 28 | 
| Change in Urine Routine | Numerical change in Urine Routine | Change from Baseline Urine Routine at Day 28 | 
| Health Assessment Questionnaire Disability Index, HAQ-DI | Questionnaire | Change from Baseline HAQ-DI at Day 28 | 
| Disease Activity Score, DAS 28 | A score of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission. | Change from Baseline DAS 28 at Day 28 |