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

May 5, 2024 updated by: HoHo Biotech
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
        • Principal Investigator:
          • Min Chung Shen, M.D.
        • Sub-Investigator:
          • Feng-Cheng Liu, M.D., PhD
        • Sub-Investigator:
          • Szu Han Chiu, M.D.
      • Taoyuan, Taiwan
        • Recruiting
        • Taoyuan Armed Forces General Hospital
        • Contact:
        • Principal Investigator:
          • Min Chung Shen, M.D.
        • Sub-Investigator:
          • Feng-Cheng Liu, M.D., PhD
        • Sub-Investigator:
          • Szu Han Chiu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo supplement
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.
Experimental: Hydrogen capsules
Hydrogen supplement
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Blood Routine
Time Frame: Change from Baseline of Blood Routine, and every return per 4 weeks during 24 weeks of the intervention
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
Time Frame: Change from Baseline of Urine Routine, and every return per 4 weeks during 24 weeks of the intervention
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
Time Frame: Change from Baseline of HAQ-DI, and every return per 4 weeks during 24 weeks of the intervention
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)
Time Frame: Change from Baseline of DAS 28, and every return per 4 weeks during 24 weeks of the intervention
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)
Time Frame: Change from Baseline of BFI-T, and every return per 4 weeks during 24 weeks of the intervention
Change in the BFI-T
Change from Baseline of BFI-T, and every return per 4 weeks during 24 weeks of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HoHo Biotech

Collaborators

Tri-Service General Hospital
Taoyuan Armed Forces General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 11, 2024

Primary Completion (Estimated)

December 29, 2024

Study Completion (Estimated)

January 29, 2025

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

May 5, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 5, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C202305150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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