An interventional study of intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week period in Cardiovascular Diseases, Hypertension and Blood Pressure, sponsored by Indonesia Molecule Institute. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Indonesia Molecule Institute · Not applicable, Interventional, and Treatment
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:
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:
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 52 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Participants will be eligible for inclusion in the study if they meet all of the following criteria:
Exclusion Criteria
Participants will be excluded from the study if they meet any of the following criteria:
This study was designed as a randomized, single-blind, dose-response clinical trial consisting of six distinct arms. The first arm served as the control group, where participants received 500 mL of normal saline without any hydrogen nanobubbles, functioning as a placebo. The remaining five arms were intervention groups that received intravenous infusions of hydrogen nanobubbles (HNBs) at different doses. Specifically, participants in Arm B received 5 mL of HNB, Arm C received 10 mL of HNB, Arm D received 15 mL of HNB, Arm E received 20 mL of HNB, and Arm F received 25 mL of HNB, with each dose diluted in normal saline. All participants underwent a total of 10 infusion sessions over a period of 5 weeks, receiving treatments twice weekly. The study was conducted under single-blind conditions. This multi-arm design allowed the researchers to systematically evaluate the dose-dependent effects of HNB therapy on cardiovascular function, blood biomarkers, and health-related quality of life.
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.
Cardiovascular Physiology
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)
Time frame: From enrollment to the end of treatment at 6 weeks
Health-Related Quality of Life (HRQoL)
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.
Time frame: From enrollment to the end of treatment at 6 weeks
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