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Completed

NCT Number: NCT05753436

Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

The aim of the study is to assess the safety and efficacy of Curcumin supplementation in combination to the conventional therapy in improving the clinical outcomes, oxidative stress and inflammation in diabetic patients with risk of ASCVD.

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Key information

About this study

Atherosclerotic cardiovascular disease (ASCVD) is one of the most devastating consequences of Diabetes Mellitus (DM), especially when combined with other comorbid conditions such as dyslipidemia and hypertension. To lessen the probability of ASCVD, modifying an individual's lifestyle and regulating one's lipid profile, blood pressure, and glucose levels are all beneficial approaches that decrease the risk of ASCVD occurrence. Numerous diseases, including hypertension, dyslipidemia, and diabetes mellitus, have been shown to be significantly influenced by both oxidative stress and inflammation. Curcumin is thought to regulate blood pressure, lipid profile, blood glucose levels. Moreover, It is claimed that curcumin can alleviate inflammation and oxidative stress. Curcumin is therefore suggested to have a beneficial role in lowering the risk of atherosclerotic cardiovascular diseases.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult Male or female patients aged 40 years or older
  • A calculated 10 year ASCVD risk score of 5 % or more
  • Patient previously or newly diagnosed with hypertension
  • Patient previously or newly diagnosed with dyslipidaemia
  • Patients diagnosed as Type 2 diabetes mellitus taking insulin or oral hypoglycemic agent with controlled HbA1c < 10%
  • Willingness and ability to give informed consent.

Exclusion criteria

  • Congenital or acquired bleeding disorders.
  • Cholelithiasis, gall bladder or biliary tract disease or other active liver diseases.
  • Pregnant or breastfeeding women.
  • Oral hypoglycemic drugs that affect cardiovascular diseases risk.
  • Patients with clinical ASCVD (myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease).

Treatment and study plan

Puritans Pride Turmeric curcumin® 500 mg

Dietary Supplement

Turmeric curcumin 500 mg per oral capsule of Puritans Pride company supplement composed of Turmeric (curcuma longa) root 450mg and Turmeric extract (curcuma longa root 50mg ) standardized to contain 95%curcuminoids.It is added because of its possibility to reduce the risk of ASCVD by lowering blood pressure, lipid profile, blood glucose, inflammation, and oxidative stress.

Other names: Curcumin

Primary outcomes

  1. (Atherosclerotic cardiovascular diseases risk score) Low-risk (<5%) Borderline risk (5% to 7.4%) Intermediate risk (7.5% to 19.9%) High risk (≥20%)

    Time frame: Change from Baseline ASCVD risk scoring at 14 weeks

    10 year ASCVD risk calculation by using Pooled cohort equations

  2. Blood Glucose Level

    Time frame: Change from Baseline Blood Glucose Level at 14 weeks

    Fasting blood glucose (FBG) in mg/dl , Hemoglobin A1c (HbA1c) in percentage

  3. Lipid Profile

    Time frame: Change from Baseline Lipid profile at 14 weeks

    Serum sample to determine ( Triglyceride level , LDL ,HDL ,Total cholesterol ) in mg/dl

  4. Blood Pressure

    Time frame: Change from Baseline Blood Pressure at 14 weeks

    (SBP and DBP) in mmHg by using Sphygmomanometer

  5. Heart Rate

    Time frame: Change from Baseline Heart Rate at 14 weeks

    Pulse in bpm

Secondary outcomes

  1. Concentration of Tumor necrosis factor alpha ( TNF-alpha)

    Time frame: Change from Baseline TNF-alpha concentration at 14 weeks

    Serum sample to determine TNF alpha (Inflammatory biomarker)

  2. Concentration of Malondialdehyde (MDA)

    Time frame: Change from Baseline MDA concentration at 14 weeks

    Serum sample to determine MDA (Oxidative stress marker)

  3. International normalized ratio

    Time frame: Change from Baseline INR level at 14 weeks

    Blood sample to determine INR level for those patients receiving anticoagulants

  4. Serum Ferritin

    Time frame: Change from Baseline Ferritin concentration at 14 weeks

    Serum Ferritin for those patients who are suspected to be anemic or are anemic.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluation of the Effect of Curcumin Administration on the Clinical Outcome of Diabetic Patients With Atherosclerotic Cardiovascular Risk

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2023
Registry last updated
Aug 22, 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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