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

Phase 1

• Conditions: Autoimmune Diseases; Metabolic Disease
• Interventions: Drug: Hydrogen

• Registration Number: NCT05196295
• Lead Sponsor: HoHo Biotech

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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-03
• Study Start: 2022-01-11
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-19
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-10
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydrogen capsules	Hydrogen	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.

Primary Outcome Measures

Name	Time	Method
Adverse effects/symptoms	up to 28 days	Any adverse effects will be codified according the the NCI CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
Change in physiological parameter (Urine Routine)	Change from Baseline Urine Routine at Day 28	Numerical change in Urine Routine
Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions)	Change from Baseline BFI-T at Day 28	Questionnaire for rheumatologic patients minimum values:0 maximum values:60 Higher scores mean a worse outcome.
Change in physiological parameter (Blood Routine)	Change from Baseline Blood Routine at Day 28	Numerical change in Blood Routine
Control status scale for diabetics (CSSD70) (First part: 11 questions)	Change from Baseline CSSD70 at Day 28	Questionnaire for metabolic patients minimum values:0 maximum values:22 Higher scores mean a worse outcome.

Trial Locations

Locations (1)

Min-Sheng Gereral hospital; 🇨🇳 Taoyuan, Taiwan