Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

August 17, 2025 updated by: Omar El Rakabawy, Ain Shams University

Evaluation of the Effect of Curcumin Administration on the Clinical Outcome of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Demerdash Hospital, Faculty of Medicine, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1, Curcumin group
Group 1, Curcumin group (n=36): Patients will receive conventional treatment co-administrated with Turmeric Curcumin 500 mg thrice daily for 14 weeks.
Dietary supplement: Puritans Pride Turmeric curcumin® 500 mg
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
No Intervention: Group 2, Control group
Group 2, Control group (n= 36): Patients will receive conventional therapy alone for 14 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(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
Change from Baseline ASCVD risk scoring at 14 weeks
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
Change from Baseline Blood Glucose Level at 14 weeks
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
Change from Baseline Lipid profile at 14 weeks
Blood Pressure
Time Frame: Change from Baseline Blood Pressure at 14 weeks
(SBP and DBP) in mmHg by using Sphygmomanometer
Change from Baseline Blood Pressure at 14 weeks
Heart Rate
Time Frame: Change from Baseline Heart Rate at 14 weeks
Pulse in bpm
Change from Baseline Heart Rate at 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from Baseline TNF-alpha concentration at 14 weeks
Concentration of Malondialdehyde (MDA)
Time Frame: Change from Baseline MDA concentration at 14 weeks
Serum sample to determine MDA (Oxidative stress marker)
Change from Baseline MDA concentration at 14 weeks
International normalized ratio
Time Frame: Change from Baseline INR level at 14 weeks
Blood sample to determine INR level for those patients receiving anticoagulants
Change from Baseline INR level at 14 weeks
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.
Change from Baseline Ferritin concentration at 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 17, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHDIRB2020110301 REC#120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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