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

Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196295
• Other study ID #: 2021007-A
• Status: Recruiting
• Phase: Phase 1
• Start date: January 11, 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: January 2022
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Metabolic Disease
• Metabolic Diseases

Intervention

Drug:
• Hydrogen
Participants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.

Locations

Country	Name	City	State
Taiwan	Min-Sheng Gereral hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
HoHo Biotech

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse effects/symptoms	Any adverse effects will be codified according the the NCI CTCAE v5.0	up to 28 days
Secondary	Change in physiological parameter (Blood Routine)	Numerical change in Blood Routine	Change from Baseline Blood Routine at Day 28
Secondary	Change in physiological parameter (Urine Routine)	Numerical change in Urine Routine	Change from Baseline Urine Routine at Day 28
Secondary	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
Secondary	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