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IV Hydrogen Nanobubbles for Cardiac Function and QoL

NCT07085637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-07-30

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Indonesia Molecule Institute

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2022-11-04
Completion
2022-11-04

Countries

  • Indonesia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085637 on ClinicalTrials.gov