Clinical trial NCT06401785: To Evaluate the Efficacy of Oral Molecular Hydrogen Supplement in Patients With Chronic Diseases
Official title: To Evaluate the Efficacy of Oral Molecular Hydrogen Supplement in Patients With Chronic Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Disease
Chronic Inflammation
Keywords: Hydrogen supplement
Oral hydrogen capsules
Lead sponsor: HoHo Biotech
Sponsor class: INDUSTRY
Collaborators: name: Taoyuan Armed Forces General Hospital
name: Tri-Service General Hospital
First posted: 2024-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in Blood Routine
timeFrame: Change from Baseline of Blood Routine, and every return per 4 weeks during 24 weeks of the intervention
measure: Improvement in Urine Routine
timeFrame: Change from Baseline of Urine Routine, and every return per 4 weeks during 24 weeks of the intervention
measure: Improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) Questionnaire
timeFrame: Change from Baseline of HAQ-DI, and every return per 4 weeks during 24 weeks of the intervention
measure: Improvement in the Disease Activity Score (DAS 28)
timeFrame: Change from Baseline of DAS 28, and every return per 4 weeks during 24 weeks of the intervention
measure: Improvement in the Brief Fatigue Inventory-Taiwan (BFI-T)
timeFrame: Change from Baseline of BFI-T, and every return per 4 weeks during 24 weeks of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Taoyuan Armed Forces General Hospital
Study officials:
References: