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

NCT06401785 | Recruiting Phase 2

• 1 other identifier: C202305150
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Disease; Chronic Inflammation

Keywords

Hydrogen supplement; Oral hydrogen capsules

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Hydrogen capsules

EXPERIMENTAL

Hydrogen supplement

Dietary Supplement: Hydrogen capsules

Placebo

PLACEBO COMPARATOR

Placebo supplement

Dietary Supplement: Hydrogen capsules

Interventions

Hydrogen capsules DIETARY_SUPPLEMENT

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.

Hydrogen capsules; Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• HoHo Biotech: lead
• Taoyuan Armed Forces General Hospital: collaborator
• Tri-Service General Hospital: collaborator

Study Sites (2)

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

Taoyuan Armed Forces General Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Interventions

Hydrogen

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Gases

Central Study Contacts

Kuang-Yih Wang, M.D.

CONTACT

+886 920757313; bbban1024@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: May 7, 2024
• Study Start: May 11, 2024
• Primary Completion: December 29, 2024
• Study Completion: January 29, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

TW (2)