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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HoHo Biotech

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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