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

Last updated: November 2, 2021
Sponsor: HoHo Biotech
Overall Status: Active - Recruiting

Phase

1

Condition

Connective Tissue Diseases

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT05116215
IRB-B202105106
  • Ages 20-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Pregnancy
  • Expected pregnancy

Study Design

Total Participants: 27
Study Start date:
August 13, 2021
Estimated Completion Date:
August 12, 2022

Study 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.

Connect with a study center

  • Tri-Service General Hospital

    Taipei,
    Taiwan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.