To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.
Primary Purpose
Autoimmune Diseases, Metabolic Disease
Status
Recruiting
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 70 with autoimmune or metabolic diseases
- Able to compliant with the protocol
- Able to return to the hospital regularly
Exclusion Criteria:
- Pregnancy
- Expected pregnancy
Sites / Locations
- Min-Sheng Gereral hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hydrogen capsules
Arm Description
Participants will be allocated by doctors and receive either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.
Outcomes
Primary Outcome Measures
Adverse effects/symptoms
Any adverse effects will be codified according the the NCI CTCAE v5.0
Secondary Outcome Measures
Change in physiological parameter (Blood Routine)
Numerical change in Blood Routine
Change in physiological parameter (Urine Routine)
Numerical change in Urine Routine
Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions)
Questionnaire for rheumatologic patients minimum values:0 maximum values:60 Higher scores mean a worse outcome.
Control status scale for diabetics (CSSD70) (First part: 11 questions)
Questionnaire for metabolic patients minimum values:0 maximum values:22 Higher scores mean a worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05196295
Brief Title
To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.
Official Title
To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With 3 Increasing Doses of Molecular Hydrogen Supplement.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HoHo Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The latest international research shows that supplementation of hydrogen molecules as an aid, adjuvant, can speed up the course of the disease. The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different dose exposures for a clinical study in rheumatologic and metabolic patients. Patients will receive a different dosage of hydrogen capsules 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
According to the current literature, there is a lack of specific drugs for chronic inflammatory symptoms which develop from many refractory diseases with complicated clinical features. Hydrogen supplement has been shown to have significant removal effects on free radicals and reduce chronic inflammation. With these benefits, molecular hydrogen may have the ability to speed up the recovering the disease.
The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in the different doses of hydrogen capsules for a clinical study in rheumatologic and metabolic patients.
Study design: 15 rheumatologic patients and 15 metabolic patients will be recruited from the Min-Sheng 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 (Low, n=5; Medium, n=5; High, n=5). Participants will receive 1 (Low), 3 (Medium) or 6 (High) capsules 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, Metabolic Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrogen capsules
Arm Type
Experimental
Arm Description
Participants will be allocated by doctors and receive either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.
Intervention Type
Drug
Intervention Name(s)
Hydrogen
Intervention Description
Participants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.
Primary Outcome Measure Information:
Title
Adverse effects/symptoms
Description
Any adverse effects will be codified according the the NCI CTCAE v5.0
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Change in physiological parameter (Blood Routine)
Description
Numerical change in Blood Routine
Time Frame
Change from Baseline Blood Routine at Day 28
Title
Change in physiological parameter (Urine Routine)
Description
Numerical change in Urine Routine
Time Frame
Change from Baseline Urine Routine at Day 28
Title
Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions)
Description
Questionnaire for rheumatologic patients minimum values:0 maximum values:60 Higher scores mean a worse outcome.
Time Frame
Change from Baseline BFI-T at Day 28
Title
Control status scale for diabetics (CSSD70) (First part: 11 questions)
Description
Questionnaire for metabolic patients minimum values:0 maximum values:22 Higher scores mean a worse outcome.
Time Frame
Change from Baseline CSSD70 at Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 20 to 70 with autoimmune or metabolic diseases
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
Min-Sheng Gereral hospital
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Wen Chen
Phone
03 479 4151
Ext
5506
Email
N002737@e-ms.com.tw
First Name & Middle Initial & Last Name & Degree
Min-Chung Shen, M.D.
First Name & Middle Initial & Last Name & Degree
Szu-Han Chiu, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.
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