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

Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05116215
• Other study ID #: IRB-B202105106
• Status: Recruiting
• Phase: Phase 1
• Start date: August 13, 2021
• Est. completion date: August 12, 2022

Study information

• Verified date: October 2021
• Source: HoHo Biotech
• Contact: Kuang-Yih Wang, M.D.
• Phone: +886 920757313
• Email: bbban1024[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: August 12, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy
• Expected pregnancy

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

Drug:
• Hydrogen
Hydrogen supplement

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
HoHo Biotech	Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Blood Routine	Numerical change in Blood Routine	Change from Baseline Blood Routine at Day 28
Primary	Change in Urine Routine	Numerical change in Urine Routine	Change from Baseline Urine Routine at Day 28
Primary	Health Assessment Questionnaire Disability Index, HAQ-DI	Questionnaire	Change from Baseline HAQ-DI at Day 28
Primary	Disease Activity Score, DAS 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