Efficacy and Safety of Portable Hydrogen Rich Water Machine is Used for Adjuvant Treatment of Patients With Hyperlipidemia

Launched by SUN JIA · Mar 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a portable hydrogen-rich water machine as an additional treatment for people with hyperlipidemia, which means they have high levels of fats (lipids) in their blood. High lipid levels can lead to serious health issues like heart disease. The trial aims to see if drinking hydrogen-rich water can help lower bad cholesterol and improve overall health by reducing oxidative stress and inflammation in the body.

To participate, individuals must be between 18 and 65 years old and have a clinical diagnosis of hyperlipidemia. They should not have certain underlying health conditions or be taking specific medications that affect lipid levels. Participants will drink hydrogen-rich water daily and will be monitored for any changes in their cholesterol levels and overall health. This study is important because there is still limited research on how hydrogen water can help manage hyperlipidemia, and it may offer a new way to support heart health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-65 (inclusive), gender is not limited;
• • Subjects with clinical diagnosis of hyperlipidemia;
• • The subjects' fasting LDL-C and carotid artery color Doppler ultrasound meet one of the following requirements: 1. Bilateral carotid artery color Doppler shows no plaque formation, and 2.6 ≤ LDL-C \< 4.92mmol/L; 2. Bilateral or unilateral neck Arterial plaque formation, and 2.6≤LDL-C\<3.4mmol/L;
• • 18.5 kg/m2≤BMI≤35 kg/m2, Body mass index (BMI) is calculated by dividing body weight (kg) by the square of height (m2);
• • Subjects who are willing to participate in the trial and sign informed consent.
• Exclusion Criteria:
• • Secondary hyperlipidemia caused by systemic diseases (such as nephrotic syndrome, hypothyroidism, systemic lupus erythematosus, glycogen storage disease, liver disease or renal failure, etc.);
• • Fasting triglycerides \> 5.6 mmol/L;
• • Diabetic patients;
• • Those who plan to undergo bariatric surgery (gastric retraction, gastric bypass, gastric banding, etc.) during the study period;
• • Have taken or plan to take lipid-lowering drugs within the last 8 weeks (eg, statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, fibrates, proprotein convertase subtilisin 9 (PCSK9) ) inhibitors, Xuezhikang and Chinese patent medicines with lipid-lowering effect, etc.) who intervene;
• • Those who have taken or plan to take lipid-lowering drugs within the last 8 weeks (eg, statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, fibrates, proprotein convertase subtilisin 9 (PCSK9) inhibitors, Xuezhikang and Chinese patent medicines with lipid-lowering effect, etc.);
• • Subjects who have used heparin, thyroxine treatment drugs, diuretics, phenothiazines, beta-blockers, adrenal corticosteroids and certain contraceptives in the past 8 weeks, which may affect blood lipid metabolism;
• • Combined with malignant tumor or mental disorder;
• • Accompanied by severe cardiovascular and cerebrovascular diseases, liver and kidney function damage (NYHA grade greater than or equal to 3, ALT or AST \> 3 times the upper limit of normal, Cr \> 1.5 times the upper limit of normal);
• • Those who have participated in clinical trials of other drugs or medical devices within 3 months;
• • Those who plan to become pregnant, are pregnant or are breastfeeding during the study period and those who cannot take contraceptive measures;
• • Patients deemed unsuitable for participation in this study by the investigator.