Demerdash Hospital, Faculty of Medicine, Ain Shams University
Cairo, Egypt
NCT Number: NCT05753436
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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Notify Me40 year and older
All sexes
Interventional
Phase 2
Cairo, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Change from Baseline ASCVD risk scoring at 14 weeks
10 year ASCVD risk calculation by using Pooled cohort equations
Time frame: Change from Baseline Blood Glucose Level at 14 weeks
Fasting blood glucose (FBG) in mg/dl , Hemoglobin A1c (HbA1c) in percentage
Time frame: Change from Baseline Lipid profile at 14 weeks
Serum sample to determine ( Triglyceride level , LDL ,HDL ,Total cholesterol ) in mg/dl
Time frame: Change from Baseline Blood Pressure at 14 weeks
(SBP and DBP) in mmHg by using Sphygmomanometer
Time frame: Change from Baseline Heart Rate at 14 weeks
Pulse in bpm
Time frame: Change from Baseline TNF-alpha concentration at 14 weeks
Serum sample to determine TNF alpha (Inflammatory biomarker)
Time frame: Change from Baseline MDA concentration at 14 weeks
Serum sample to determine MDA (Oxidative stress marker)
Time frame: Change from Baseline INR level at 14 weeks
Blood sample to determine INR level for those patients receiving anticoagulants
Time frame: Change from Baseline Ferritin concentration at 14 weeks
Serum Ferritin for those patients who are suspected to be anemic or are anemic.
Ain Shams University
Other
Evaluation of the Effect of Curcumin Administration on the Clinical Outcome of Diabetic Patients With Atherosclerotic Cardiovascular Risk
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