To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.
1 other identifier
interventional
30
1 country
1
Brief Summary
The latest international research shows that supplementation of hydrogen molecules as an aid, adjuvant, can speed up the course of the disease. The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different dose exposures for a clinical study in rheumatologic and metabolic patients. Patients will receive a different dosage of hydrogen capsules 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 Jan 2022
Shorter than P25 for phase_1
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
First Submitted
Initial submission to the registry
January 3, 2022
CompletedStudy Start
First participant enrolled
January 11, 2022
CompletedFirst Posted
Study publicly available on registry
January 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedFebruary 10, 2022
January 1, 2022
7 months
January 3, 2022
January 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse effects/symptoms
Any adverse effects will be codified according the the NCI CTCAE v5.0
up to 28 days
Secondary Outcomes (4)
Change in physiological parameter (Blood Routine)
Change from Baseline Blood Routine at Day 28
Change in physiological parameter (Urine Routine)
Change from Baseline Urine Routine at Day 28
Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions)
Change from Baseline BFI-T at Day 28
Control status scale for diabetics (CSSD70) (First part: 11 questions)
Change from Baseline CSSD70 at Day 28
Study Arms (1)
Hydrogen capsules
EXPERIMENTALParticipants will be allocated by doctors and receive either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.
Interventions
Participants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.
Eligibility Criteria
You may qualify if:
- Age 20 to 70 with autoimmune or metabolic diseases
- 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
Study Sites (1)
Min-Sheng Gereral hospital
Taoyuan District, Taiwan
Related Publications (1)
Chiu SH, Douglas FL, Chung JR, Wang KY, Chu CF, Chou HY, Huang WC, Wang TY, Chen WW, Shen MC, Liu FC, Hsiao PJ. Evaluation of the safety and potential lipid-lowering effects of oral hydrogen-rich coral calcium (HRCC) capsules in patients with metabolic syndrome: a prospective case series study. Front Nutr. 2023 Jul 14;10:1198524. doi: 10.3389/fnut.2023.1198524. eCollection 2023.
PMID: 37521410DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2022
First Posted
January 19, 2022
Study Start
January 11, 2022
Primary Completion
July 30, 2022
Study Completion
July 30, 2022
Last Updated
February 10, 2022
Record last verified: 2022-01