NCT05116215

To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: HoHo Biotech · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	Hydrogen	Hydrogen supplement

Timeline

• Start date: 2021-08-13
• Primary completion: 2022-08-12
• Completion: 2022-08-12
• First posted: 2021-11-10
• Last updated: 2021-11-10

Locations

1 site across 1 country: Taiwan