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

Phase 1

• Conditions: Autoimmune Diseases
• Interventions: Drug: Hydrogen

• Registration Number: NCT05116215
• Lead Sponsor: HoHo Biotech

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.

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 Timeline

• Study Start: 2021-08-13
• Status Verified: 2021-10
• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-11-02
• Last Update Submitted: 2021-11-02
• Study First Posted: 2021-11-10
• Last Update Posted: 2021-11-10
• Primary Completion: 2022-08-12
• Study Completion: 2022-08-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Age 20 to 80
• Able to compliant with the protocol
• Able to return to the hospital regularly

Exclusion Criteria

• Pregnancy
• Expected pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrogen capsules	Hydrogen	Participants in capsule group will receive either 1 (n=3), 3 (n=3) or 6 (n=3) capsules every day for one month.
Hydrogen inhalation	Hydrogen	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.
Hydrogen water	Hydrogen	Participants in the water group will be suggested to drink 1 L hydrogen-rich water every day for one month.

Primary Outcome Measures

Name	Time	Method
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.
Change in Blood Routine	Change from Baseline Blood Routine at Day 28	Numerical change in Blood Routine
Health Assessment Questionnaire Disability Index, HAQ-DI	Change from Baseline HAQ-DI at Day 28	Questionnaire
Change in Urine Routine	Change from Baseline Urine Routine at Day 28	Numerical change in Urine Routine

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan