NCT07085637

IV Hydrogen Nanobubbles for Cardiac Function and QoL

Intravenous Hydrogen Nanobubbles Effect on Cardiac Physiology and Quality of Life: a Single Blind, Dose-response Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Indonesia Molecule Institute · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if intravenous hydrogen nanobubbles (HNBs) improve cardiovascular function and quality of life in adults. It will also explore the dose-dependent effects of HNBs when given through IV infusion. The main questions it aims to answer are: 1. Do HNBs improve heart function and blood vessel health (e.g., blood pressure, ejection fraction, flow-mediated dilation)? 2. How do different doses of HNBs affect quality of life as measured by the SF-36 questionnaire? 3. Are there any safety or tolerability concerns with intravenous HNBs? Researchers will compare different doses of HNBs (5 mL to 25 mL) to a placebo (normal saline) to evaluate their physiological and psychological effects. Participants will: 1. Receive intravenous infusions twice a week for 5 weeks (10 sessions in total) 2. Be assigned randomly to one of six groups (five different HNB doses or placebo) 3. Complete quality-of-life questionnaires and undergo cardiovascular and lab tests before and after the intervention

Detailed description

This clinical study explored whether intravenous hydrogen nanobubbles (HNBs) can improve heart health and quality of life. HNBs are microscopic hydrogen gas bubbles that may help reduce oxidative stress and inflammation-two major contributors to cardiovascular disease. The research aimed to assess how different doses of HNBs affect blood pressure, heart function, blood vessel health, and overall well-being. A total of 52 healthy adults aged 18-65 took part in the trial. They were randomly assigned to receive either normal saline (as a placebo) or saline mixed with varying doses of HNBs (5-25 mL). Each participant received 10 intravenous infusions over 5 weeks, with health checks before and after. Researchers used physical exams, blood tests, heart scans, and a standardized questionnaire (SF-36) to track changes in cardiovascular function and quality of life. This study helps lay the groundwork for future research into non-drug therapies using nanotechnology. If proven effective, HNBs could become a novel, low-risk treatment option for people with high blood pressure, heart stress, or chronic inflammation-ultimately supporting both physical and emotional well-being.

Conditions

• Cardiovascular Diseases
• Hypertension
• Blood Pressure

Interventions

Type	Name	Description
OTHER	intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week period	This study investigated a novel intervention using intravenous hydrogen nanobubbles (HNBs), which are microscopic hydrogen gas bubbles encapsulated in liquid, offering enhanced stability, deep tissue penetration, and sustained antioxidant and anti-inflammatory effects. Unlike other hydrogen therapies (such as inhalation or hydrogen-rich water), this method delivers HNBs directly into the bloodstream. Participants were randomized into six groups: one control group receiving saline and five intervention groups receiving escalating doses of HNBs (5-25 mL) over 10 intravenous infusions in 5 weeks. This intervention is distinct for its dose-response design, intravenous delivery, and combined evaluation of cardiovascular function and quality of life (SF-36)-a patient-centered approach not commonly found in similar studies.

Timeline

• Start date: 2022-09-19
• Primary completion: 2022-11-04
• Completion: 2022-11-04
• First posted: 2025-07-25
• Last updated: 2025-07-30

Locations

1 site across 1 country: Indonesia