Chronic Disease, Chronic Inflammation
Conditions
Keywords
Hydrogen supplement, Oral hydrogen capsules
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTHydrogen capsules
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.
Sponsors
Taoyuan Armed Forces General Hospital
Tri-Service General Hospital
HoHo Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 20 to 80 * Able to compliant with the protocol * Able to return to the hospital regularly * Patients with chronic inflammation, including patients with autoimmune diseases, metabolic-related diseases, chronic kidney disease or nephritis, tumor patients, etc.
Exclusion criteria
* Pregnancy * Expected pregnancy * Attending other clinical trials with 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Blood Routine | Change from Baseline of Blood Routine, and every return per 4 weeks during 24 weeks of the intervention | 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 |
| Improvement in Urine Routine | Change from Baseline of Urine Routine, and every return per 4 weeks during 24 weeks of the intervention | Change in Urine Routine, including GLU, PRO, BIL, URO, PH, SG, OB, KET, NIT, Uric acid, BUN, and eGFR |
| Improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) Questionnaire | Change from Baseline of HAQ-DI, and every return per 4 weeks during 24 weeks of the intervention | Change in the (HAQ-DI) Questionnaire |
| Improvement in the Disease Activity Score (DAS 28) | Change from Baseline of DAS 28, and every return per 4 weeks during 24 weeks of the intervention | Change in the DAS 28 |
| Improvement in the Brief Fatigue Inventory-Taiwan (BFI-T) | Change from Baseline of BFI-T, and every return per 4 weeks during 24 weeks of the intervention | Change in the BFI-T |
Countries
Taiwan
Contacts
Primary ContactKuang-Yih Wang, M.D.
Outcome results
None listed