Clinical trial NCT05196295: To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.
Official title: To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With 3 Increasing Doses of Molecular Hydrogen Supplement.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Autoimmune Diseases
Metabolic Disease
Lead sponsor: HoHo Biotech
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The latest international research shows that supplementation of hydrogen molecules as an aid, adjuvant, can speed up the course of the disease. The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different dose exposures for a clinical study in rheumatologic and metabolic patients. Patients will receive a different dosage of hydrogen capsules 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: According to the current literature, there is a lack of specific drugs for chronic inflammatory symptoms which develop from many refractory diseases with complicated clinical features. Hydrogen supplement has been shown to have significant removal effects on free radicals and reduce chronic inflammation. With these benefits, molecular hydrogen may have the ability to speed up the recovering the disease.

The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in the different doses of hydrogen capsules for a clinical study in rheumatologic and metabolic patients.

Study design: 15 rheumatologic patients and 15 metabolic patients will be recruited from the Min-Sheng 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 (Low, n=5; Medium, n=5; High, n=5). Participants will receive 1 (Low), 3 (Medium) or 6 (High) capsules 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 70 with autoimmune or metabolic diseases
* Able to compliant with the protocol
* Able to return to the hospital regularly

Exclusion Criteria:

* Pregnancy
* Expected pregnancy

Primary outcomes:
measure: Adverse effects/symptoms
timeFrame: up to 28 days
Secondary outcomes:
measure: Change in physiological parameter (Blood Routine)
timeFrame: Change from Baseline Blood Routine at Day 28
measure: Change in physiological parameter (Urine Routine)
timeFrame: Change from Baseline Urine Routine at Day 28
measure: Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions)
timeFrame: Change from Baseline BFI-T at Day 28
measure: Control status scale for diabetics (CSSD70) (First part: 11 questions)
timeFrame: Change from Baseline CSSD70 at Day 28
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Min-Sheng Gereral hospital
Study officials:
References: