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To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.

To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With 3 Increasing Doses of Molecular Hydrogen Supplement.

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05196295
Enrollment
30
Registered
2022-01-19
Start date
2022-01-11
Completion date
2022-07-30
Last updated
2022-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases, Metabolic Disease

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.

Detailed description

According to the current literature, there is a lack of specific drugs for chronic inflammatory symptoms which develop from many refractory diseases with complicated clinical features. Hydrogen supplement has been shown to have significant removal effects on free radicals and reduce chronic inflammation. With these benefits, molecular hydrogen may have the ability to speed up the recovering the disease. The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in the different doses of hydrogen capsules for a clinical study in rheumatologic and metabolic patients. Study design: 15 rheumatologic patients and 15 metabolic patients will be recruited from the Min-Sheng 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 (Low, n=5; Medium, n=5; High, n=5). Participants will receive 1 (Low), 3 (Medium) or 6 (High) capsules every day for one month. Participants will be examined their regular haematology, urine and health status before and after the intervention.

Interventions

Participants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.

Sponsors

HoHo Biotech
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age 20 to 70 with autoimmune or metabolic diseases * Able to compliant with the protocol * Able to return to the hospital regularly

Exclusion criteria

* Pregnancy * Expected pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Adverse effects/symptomsup to 28 daysAny adverse effects will be codified according the the NCI CTCAE v5.0

Secondary

MeasureTime frameDescription
Change in physiological parameter (Blood Routine)Change from Baseline Blood Routine at Day 28Numerical change in Blood Routine
Change in physiological parameter (Urine Routine)Change from Baseline Urine Routine at Day 28Numerical change in Urine Routine
Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions)Change from Baseline BFI-T at Day 28Questionnaire for rheumatologic patients minimum values:0 maximum values:60 Higher scores mean a worse outcome.
Control status scale for diabetics (CSSD70) (First part: 11 questions)Change from Baseline CSSD70 at Day 28Questionnaire for metabolic patients minimum values:0 maximum values:22 Higher scores mean a worse outcome.

Countries

Taiwan

Contacts

Primary ContactKuang-Yih Wang, M.D.
bbban1024@gmail.com+886 920757313

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026