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Completed

NCT Number: NCT07085637

IV Hydrogen Nanobubbles for Cardiac Function and QoL

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

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Key information

Conditions

Cardiovascular Diseases Blood Pressure Hypertension Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indonesia Molecule Institute

Malang, East Java, 65151, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants will be eligible for inclusion in the study if they meet all of the following criteria:

  • Aged between 18 and 65 years at the time of screening.
  • Demonstrated stable health condition, as determined by medical history and baseline clinical evaluation.
  • Willing and able to provide written informed consent.
  • Able to comply with study procedures and agree to maintain normal daily activities and dietary patterns throughout the study period.

Exclusion criteria

Participants will be excluded from the study if they meet any of the following criteria:

  • Known or suspected hypersensitivity to hydrogen or hydrogen-based products.
  • Current participation in another interventional clinical trial.
  • Diagnosed with advanced or uncontrolled cardiovascular, renal, or hepatic disease.
  • Any other medical or psychological condition that, in the opinion of the investigators, could compromise the participant's safety or the integrity of the study data.

Treatment and study plan

intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week period

Other

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.

Primary outcomes

  1. Cardiovascular Physiology

    Time frame: From enrollment to the end of treatment at 6 weeks

    Primary cardiovascular function outcomes included systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg); heart rate, expressed in beats per minute (bpm); and left ventricular ejection fraction (LVEF), reported as a percentage. Diastolic function was assessed through early diastolic mitral inflow velocity (EVel), lateral mitral annular velocity (ELat), and septal mitral annular velocity (ESep), all expressed in meters per second (m/s). Left Ventricular Mass divided by Body Surface Area (BSA) to report Left Ventricular Mass Index in (g/m²), relative wall thickness (RWT), presented as a unitless ratio; tricuspid annular plane systolic excursion (TAPSE), interventricular septal thickness in diastole (IVSd), left ventricular internal dimension in diastole (LVIDd), and left ventricular posterior wall thickness in diastole (LVPWD), all reported in centimeters (cm).Flow-mediated dilation (FMD) (% change in vessel diameter)

  2. Health-Related Quality of Life (HRQoL)

    Time frame: From enrollment to the end of treatment at 6 weeks

    The study evaluated health-related quality of life (HRQoL) using the 36-Item Short Form Health Survey (SF-36), a validated instrument consisting of eight distinct domains: General Health (GH), Physical Functioning (PF), Role Limitations due to Physical Health (PH), Bodily Pain (BP), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (EL), and Mental Health (MH). Each domain was treated as a separate outcome measure and scored individually on a scale from 0 to 100, where higher scores reflect better health status in that specific domain. In accordance with reporting standards, each SF-36 domain was analyzed and reported independently, rather than being combined into a single summary score. Although all domains share the same unit (0-100 scale), they assess different dimensions of physical and mental well-being and are therefore presented as distinct outcome variables.

Sponsors and collaborators

Lead sponsor

Indonesia Molecule Institute

Network

Registry information

Official study title

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

Acronym: HNB

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 25, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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