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

Phase 2

Recruiting

• Conditions: Chronic Inflammation; Chronic Disease

• Registration Number: NCT06401785
• Lead Sponsor: HoHo Biotech

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 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.

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 Timeline

• Study First Submitted: 2024-02-18
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-05
• Last Update Submitted: 2024-05-05
• Study First Posted: 2024-05-07
• Last Update Posted: 2024-05-07
• Study Start: 2024-05-11
• Primary Completion: 2024-12-29
• Study Completion: 2025-01-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in the Disease Activity Score (DAS 28)	Change from Baseline of DAS 28, and every return per 4 weeks during 24 weeks of the intervention	Change in the DAS 28
Improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) Questionnaire	Change from Baseline of HAQ-DI, and every return per 4 weeks during 24 weeks of the intervention	Change in the (HAQ-DI) Questionnaire
Improvement in Blood Routine	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
Improvement in Urine Routine	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
Improvement in the Brief Fatigue Inventory-Taiwan (BFI-T)	Change from Baseline of BFI-T, and every return per 4 weeks during 24 weeks of the intervention	Change in the BFI-T

Trial Locations

Locations (2)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan

Taoyuan Armed Forces General Hospital; 🇨🇳 Taoyuan, Taiwan