Clinical trial NCT05116215: To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement
Official title: To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Autoimmune Diseases
Lead sponsor: HoHo Biotech
Sponsor class: INDUSTRY
Collaborators: name: Tri-Service General Hospital
First posted: 2021-11-10
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy
* Expected pregnancy

Primary outcomes:
measure: Change in Blood Routine
timeFrame: Change from Baseline Blood Routine at Day 28
measure: Change in Urine Routine
timeFrame: Change from Baseline Urine Routine at Day 28
measure: Health Assessment Questionnaire Disability Index, HAQ-DI
timeFrame: Change from Baseline HAQ-DI at Day 28
measure: Disease Activity Score, DAS 28
timeFrame: Change from Baseline DAS 28 at Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References: