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

November 2, 2021 updated by: HoHo Biotech
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
          • Feng-Cheng Liu, M.D., Ph.D.
          • Phone Number: 16672 +886 2 87923311
          • Email: lfc10399@gmail.com
        • Principal Investigator:
          • Feng-Cheng Liu, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Routine
Time Frame: Change from Baseline Blood Routine at Day 28
Numerical change in Blood Routine
Change from Baseline Blood Routine at Day 28
Change in Urine Routine
Time Frame: Change from Baseline Urine Routine at Day 28
Numerical change in Urine Routine
Change from Baseline Urine Routine at Day 28
Health Assessment Questionnaire Disability Index, HAQ-DI
Time Frame: Change from Baseline HAQ-DI at Day 28
Questionnaire
Change from Baseline HAQ-DI at Day 28
Disease Activity Score, DAS 28
Time Frame: 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 from Baseline DAS 28 at Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HoHo Biotech

Collaborators

Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2021

Primary Completion (Anticipated)

August 12, 2022

Study Completion (Anticipated)

August 12, 2022

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-B202105106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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