To Evaluate the Efficacy of Oral Molecular Hydrogen Supplement in Patients With Chronic Diseases

Chronic Disease Clinical Trial

Official title:

To Evaluate the Efficacy of Oral Molecular Hydrogen Supplement in Patients With Chronic Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06401785
• Other study ID #: C202305150
• Status: Recruiting
• Phase: Phase 2
• Start date: May 11, 2024
• Est. completion date: January 29, 2025

Study information

• Verified date: May 2024
• 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 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 possible efficacy and safety of solid hydrogen supplements for a clinical study in patients with chronic diseases. Patients will receive hydrogen capsules with their conventional treatment for 24 weeks. Investigators will test for any changes in haematologic, urine analysis and health status during and following the exposure period.

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 possible efficacy and safety of hydrogen supplements in different formula and dose exposures for a clinical study in patients with chronic diseases.Study design: 60 chronic diseases patients will be recruited from the Taoyuan Armed Forces General Hospital and 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 randomly allocated into 2 groups (experiment group and control group, single-blind study). In experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks. Participants will be examined their regular haematology, urine and health status before and after the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 29, 2025
• Est. primary completion date: December 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 20 to 80
• Able to compliant with the protocol
• Able to return to the hospital regularly
• Patients with chronic inflammation, including patients with autoimmune diseases, metabolic-related diseases, chronic kidney disease or nephritis, tumor patients, etc.

Exclusion Criteria:

• Pregnancy
• Expected pregnancy
• Attending other clinical trials with 6 months

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Inflammation
• Inflammation

Intervention

Dietary Supplement:
• Hydrogen capsules
In experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taoyuan Armed Forces General Hospital	Taoyuan

Sponsors (3)

Lead Sponsor	Collaborator
HoHo Biotech	Taoyuan Armed Forces General Hospital, Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Blood Routine	Change in Blood Routine, including WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Lymphocyte, Monocyte, Eosinophil, Basophil, Neutrophil, Triglyceride, Cholesterol, HDL, LDL, ESR, and CRP	Change from Baseline of Blood Routine, and every return per 4 weeks during 24 weeks of the intervention
Primary	Improvement in Urine Routine	Change in Urine Routine, including GLU, PRO, BIL, URO, PH, SG, OB, KET, NIT, Uric acid, BUN, and eGFR	Change from Baseline of Urine Routine, and every return per 4 weeks during 24 weeks of the intervention
Primary	Improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) Questionnaire	Change in the (HAQ-DI) Questionnaire	Change from Baseline of HAQ-DI, and every return per 4 weeks during 24 weeks of the intervention
Primary	Improvement in the Disease Activity Score (DAS 28)	Change in the DAS 28	Change from Baseline of DAS 28, and every return per 4 weeks during 24 weeks of the intervention
Primary	Improvement in the Brief Fatigue Inventory-Taiwan (BFI-T)	Change in the BFI-T	Change from Baseline of BFI-T, and every return per 4 weeks during 24 weeks of the intervention