To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement
Primary Purpose
Autoimmune Diseases
Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Hydrogen
Sponsored by
About this trial
This is an interventional supportive care trial for Autoimmune Diseases
Eligibility Criteria
Inclusion Criteria:
- Age 20 to 80
- Able to compliant with the protocol
- Able to return to the hospital regularly
Exclusion Criteria:
- Pregnancy
- Expected pregnancy
Sites / Locations
- Tri-Service General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Hydrogen inhalation
Hydrogen capsules
Hydrogen water
Arm Description
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 either 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.
Outcomes
Primary Outcome Measures
Change in Blood Routine
Numerical change in Blood Routine
Change in Urine Routine
Numerical change in Urine Routine
Health Assessment Questionnaire Disability Index, HAQ-DI
Questionnaire
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05116215
First Posted
October 8, 2021
Last Updated
November 2, 2021
Sponsor
HoHo Biotech
Collaborators
Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05116215
Brief Title
To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement
Official Title
To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
August 12, 2022 (Anticipated)
Study Completion Date
August 12, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HoHo Biotech
Collaborators
Tri-Service General Hospital
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrogen inhalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Hydrogen capsules
Arm Type
Experimental
Arm Description
Participants in capsule group will receive either 1 (n=3), 3 (n=3) or 6 (n=3) capsules every day for one month.
Arm Title
Hydrogen water
Arm Type
Experimental
Arm Description
Participants in the water group will be suggested to drink 1 L hydrogen-rich water every day for one month.
Intervention Type
Drug
Intervention Name(s)
Hydrogen
Intervention Description
Hydrogen supplement
Primary Outcome Measure Information:
Title
Change in Blood Routine
Description
Numerical change in Blood Routine
Time Frame
Change from Baseline Blood Routine at Day 28
Title
Change in Urine Routine
Description
Numerical change in Urine Routine
Time Frame
Change from Baseline Urine Routine at Day 28
Title
Health Assessment Questionnaire Disability Index, HAQ-DI
Description
Questionnaire
Time Frame
Change from Baseline HAQ-DI at Day 28
Title
Disease Activity Score, DAS 28
Description
A score of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
Time Frame
Change from Baseline DAS 28 at Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 20 to 80
Able to compliant with the protocol
Able to return to the hospital regularly
Exclusion Criteria:
Pregnancy
Expected pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuang-Yih Wang, M.D.
Phone
+886 920757313
Email
bbban1024@gmail.com
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng-Cheng Liu, M.D., Ph.D.
Phone
+886 2 87923311
Ext
16672
Email
lfc10399@gmail.com
First Name & Middle Initial & Last Name & Degree
Feng-Cheng Liu, M.D., Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement
We'll reach out to this number within 24 hrs