To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hydrogen inhalation 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
Hydrogen supplement
|
| Experimental: Hydrogen capsules 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
Hydrogen supplement
|
| Experimental: Hydrogen water Participants in the water group will be suggested to drink 1 L hydrogen-rich water every day for one month. |
Drug: Hydrogen
Hydrogen supplement
|
Outcome Measures
Primary Outcome Measures
- Change in Blood Routine [Change from Baseline Blood Routine at Day 28]
Numerical change in Blood Routine
- Change in Urine Routine [Change from Baseline Urine Routine at Day 28]
Numerical change in Urine Routine
- Health Assessment Questionnaire Disability Index, HAQ-DI [Change from Baseline HAQ-DI at Day 28]
Questionnaire
- Disease Activity Score, DAS 28 [Change from Baseline DAS 28 at Day 28]
A score of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 20 to 80
-
Able to compliant with the protocol
-
Able to return to the hospital regularly
Exclusion Criteria:
-
Pregnancy
-
Expected pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tri-Service General Hospital | Taipei | Taiwan |
Sponsors and Collaborators
- HoHo Biotech
- Tri-Service General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-B202105106