Cardiovascular DiseasesHNBNCT07085637
IV Hydrogen Nanobubbles for Cardiac Function and QoL
A study testing intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week period in people with Cardiovascular Diseases and Hypertension, run by Indonesia Molecule Institute at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Blood Pressure
- What is being tested?
- intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week period
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIndonesia
- Study dates
- 19 Sep 2022to 4 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Hydrogen Nanobubbles Effect on Cardiac Physiology and Quality of Life: a Single Blind, Dose-response Study
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:
Read more
- Do HNBs improve heart function and blood vessel health (e.g., blood pressure, ejection fraction, flow-mediated dilation)?
- How do different doses of HNBs affect quality of life as measured by the SF-36 questionnaire?
- 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:
- Receive intravenous infusions twice a week for 5 weeks (10 sessions in total)
- Be assigned randomly to one of six groups (five different HNB doses or placebo)
- Complete quality-of-life questionnaires and undergo cardiovascular and lab tests before and after the intervention
Read the 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
- Being tested
- intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week period
- Keywords
- hydrogen nanobubbles, cardiovascular physiology, health-related quality of life, blood pressure, myocardial relaxation
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week periodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Different dosage types | Experimental | 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. Receives: Other: intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start19 Sep 2022
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Participants were assigned to one of the following six groups, with interventions administered intravenously twice a week over a 5-week period. Group A is the control group; intervention of intravenous 500 mL of normal saline (NS) for 10 sessions over 5 weeks. Group B; intervention of 5 mL of HNB in NS i.v. for 10 sessions over 5 weeks. Group C with 10 mL HNB, group D 15 mL, group E 20mL, and group F with 25mL HNB, all done in 10 sessions over 5 weeks.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indonesia Molecule Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085637
- Sponsor's protocol ID
- No. 410/KPEK-POLKESMA/2022
- Acronym
- HNB
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Hydrogen Nanobubbles Effect on Cardiac Physiology and Quality of Life: a Single Blind, Dose-response Study
- ClinicalTrials.gov ID
- NCT07085637
- Acronym / sponsor ID
- HNB / No. 410/KPEK-POLKESMA/2022
- Conditions
- Cardiovascular Diseases, Hypertension, Blood Pressure
- Keywords
- hydrogen nanobubbles, cardiovascular physiology, health-related quality of life, blood pressure, myocardial relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Indonesia Molecule InstituteResearch network
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do HNBs improve heart function and blood vessel health (e.g., blood pressure, ejection fraction, flow-mediated dilation)?
- How do different doses of HNBs affect quality of life as measured by the SF-36 questionnaire?
- 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:
- Receive intravenous infusions twice a week for 5 weeks (10 sessions in total)
- Be assigned randomly to one of six groups (five different HNB doses or placebo)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants were assigned to one of the following six groups, with interventions administered intravenously twice a week over a 5-week period. Group A is the control group; intervention of intravenous 500 mL of normal saline (NS) for 10 sessions over 5 weeks. Group B; intervention of 5 mL of HNB in NS i.v. for 10 sessions over 5 weeks. Group C with 10 mL HNB, group D 15 mL, group E 20mL, and group F with 25mL HNB, all done in 10 sessions over 5 weeks.
| Arm | Type | Receives |
|---|---|---|
| Different dosage types | Experimental | Other: intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week periodThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week periodThis 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. | Other | Different dosage types |
Primary outcome
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week period in people with Cardiovascular Diseases and Hypertension, run by Indonesia Molecule Institute at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Physiology (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.