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

HoHo Biotech

Status and phase: Enrolling; Phase 2

Conditions: Chronic Disease; Chronic Inflammation

Treatments: Dietary Supplement: Hydrogen capsules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06401785

C202305150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Hydrogen capsules

Experimental group

Description:

Hydrogen supplement

Treatment:

Dietary Supplement: Hydrogen capsules

Placebo

Placebo Comparator group

Description:

Placebo supplement

Treatment:

Dietary Supplement: Hydrogen capsules