To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 13, 2021
CompletedFirst Submitted
Initial submission to the registry
October 8, 2021
CompletedFirst Posted
Study publicly available on registry
November 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2022
CompletedNovember 10, 2021
October 1, 2021
12 months
October 8, 2021
November 2, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (3)
Hydrogen inhalation
EXPERIMENTALParticipants 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.
Hydrogen capsules
EXPERIMENTALParticipants in capsule group will receive either 1 (n=3), 3 (n=3) or 6 (n=3) capsules every day for one month.
Hydrogen water
EXPERIMENTALParticipants in the water group will be suggested to drink 1 L hydrogen-rich water every day for one month.
Interventions
Eligibility Criteria
You may qualify if:
- Age 20 to 80
- Able to compliant with the protocol
- Able to return to the hospital regularly
You may not qualify if:
- Pregnancy
- Expected pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HoHo Biotechlead
- Tri-Service General Hospitalcollaborator
Study Sites (1)
Tri-Service General Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2021
First Posted
November 10, 2021
Study Start
August 13, 2021
Primary Completion
August 12, 2022
Study Completion
August 12, 2022
Last Updated
November 10, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share