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To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement

NCT ID: NCT05116215

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-13

Study Completion Date

2022-08-12

Brief Summary

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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 safety and possible efficacy of hydrogen supplements in different formula and dose exposures for a clinical study in rheumatologic patients. Patients will receive a different dosage of either hydrogen capsules, hydrogen gas or hydrogen-rich water with their conventional treatment for a month. Investigators will test for any changes in haematologic, urine analysis and health status during and following the exposure period.

Detailed Description

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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 safety and possible efficacy of hydrogen supplements in different formula and dose exposures for a clinical study in rheumatologic patients.

Study design: 27 rheumatologic patients will be recruited from the 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 allocated into 3 groups by different dosage forms (Gas, n=9; Water, n=9; Capsules, n=9). Participants in the gas group will then undergo exposure to 2% H2 in medical air via a high flow nasal cannula for either 1 (n=3), 2 (n=3) or 4 (n=3) hours every day for one month. Participants in capsule group will receive 1 (n=3), 3 (n=3) or 6 (n=3) capsules every day for one month. Participants in the water group will be suggested to drink 1 L hydrogen-rich water every day for one month. Participants will be examined their regular haematology, urine and health status before and after the intervention.

Conditions

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Autoimmune Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Hydrogen inhalation

Participants in the gas group will then undergo exposure to 2% H2 in medical air via a high flow nasal cannula for either 1 (n=3), 2 (n=3) or 4 (n=3) hours every day for one month.

Group Type EXPERIMENTAL

Hydrogen

Intervention Type DRUG

Hydrogen supplement

Hydrogen capsules

Participants in capsule group will receive either 1 (n=3), 3 (n=3) or 6 (n=3) capsules every day for one month.

Group Type EXPERIMENTAL

Hydrogen

Intervention Type DRUG

Hydrogen supplement

Hydrogen water

Participants in the water group will be suggested to drink 1 L hydrogen-rich water every day for one month.

Group Type EXPERIMENTAL

Hydrogen

Intervention Type DRUG

Hydrogen supplement

Interventions

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Hydrogen

Hydrogen supplement

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 20 to 80
* Able to compliant with the protocol
* Able to return to the hospital regularly

Exclusion Criteria

* Pregnancy
* Expected pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role collaborator

HoHo Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tri-Service General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kuang-Yih Wang, M.D.

Role: CONTACT

Phone: +886 920757313

Email: [email protected]

Facility Contacts

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Feng-Cheng Liu, M.D., Ph.D.

Role: primary

Other Identifiers

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IRB-B202105106

Identifier Type: -

Identifier Source: org_study_id