To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.

To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With 3 Increasing Doses of Molecular Hydrogen Supplement.

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.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Diseases; Metabolic Disease
• Intervention / Treatment: Drug: Hydrogen

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kuang-Yih Wang, M.D.; Phone Number: +886 920757313; Email: bbban1024@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Recruiting
    • Min-Sheng Gereral hospital
    • Contact: Wen-Wen Chen; Phone Number: 5506 03 479 4151; Email: N002737@e-ms.com.tw
    • Principal Investigator: Min-Chung Shen, M.D.
    • Principal Investigator: Szu-Han Chiu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrogen capsules; 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.	Drug: Hydrogen; Participants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects/symptoms	Any adverse effects will be codified according the the NCI CTCAE v5.0	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physiological parameter (Blood Routine)	Numerical change in Blood Routine	Change from Baseline Blood Routine at Day 28
Change in physiological parameter (Urine Routine)	Numerical change in Urine Routine	Change from Baseline Urine Routine at Day 28
Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions)	Questionnaire for rheumatologic patients minimum values:0 maximum values:60 Higher scores mean a worse outcome.	Change from Baseline BFI-T at Day 28
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.	Change from Baseline CSSD70 at Day 28

Collaborators and Investigators

• Sponsor: HoHo Biotech

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Metabolic Diseases
• Other Study ID Numbers: 2021007-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No