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| Name | Class |
|---|---|
| Taoyuan Armed Forces General Hospital | OTHER_GOV |
| Tri-Service General Hospital (TSGH) | OTHER |
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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 possible efficacy and safety of solid hydrogen supplements for a clinical study in patients with chronic diseases. Patients will receive hydrogen capsules with their conventional treatment for 24 weeks. Investigators will test for any changes in haematologic, urine analysis and health status during and following the exposure period.
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 possible efficacy and safety of hydrogen supplements in different formula and dose exposures for a clinical study in patients with chronic diseases.Study design: 60 chronic diseases patients will be recruited from the Taoyuan Armed Forces General Hospital and 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 randomly allocated into 2 groups (experiment group and control group, single-blind study). In experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks. Participants will be examined their regular haematology, urine and health status before and after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrogen capsules | Experimental | Hydrogen supplement |
|
| Placebo | Placebo Comparator | Placebo supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen capsules | Dietary Supplement | In experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Blood Routine | Change in Blood Routine, including WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Lymphocyte, Monocyte, Eosinophil, Basophil, Neutrophil, Triglyceride, Cholesterol, HDL, LDL, ESR, and CRP | Change from Baseline of Blood Routine, and every return per 4 weeks during 24 weeks of the intervention |
| Improvement in Urine Routine | Change in Urine Routine, including GLU, PRO, BIL, URO, PH, SG, OB, KET, NIT, Uric acid, BUN, and eGFR | Change from Baseline of Urine Routine, and every return per 4 weeks during 24 weeks of the intervention |
| Improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) Questionnaire | Change in the (HAQ-DI) Questionnaire | Change from Baseline of HAQ-DI, and every return per 4 weeks during 24 weeks of the intervention |
| Improvement in the Disease Activity Score (DAS 28) | Change in the DAS 28 | Change from Baseline of DAS 28, and every return per 4 weeks during 24 weeks of the intervention |
| Improvement in the Brief Fatigue Inventory-Taiwan (BFI-T) | Change in the BFI-T | Change from Baseline of BFI-T, and every return per 4 weeks during 24 weeks of the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuang-Yih Wang, M.D. | Contact | +886 920757313 | bbban1024@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006859 | Hydrogen |
| ID | Term |
|---|---|
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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In experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks.
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| Taoyuan Armed Forces General Hospital | Recruiting | Taoyuan | Taiwan |
|