Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

NCT ID: NCT05753436

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-03-01

Brief Summary

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.

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.

Conditions

Diabetes Mellitus, Type 2; Dyslipidemias; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Puritans Pride Turmeric curcumin® 500 mg

Intervention Type: 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.

Group 2, Control group

Group 2, Control group (n= 36): Patients will receive conventional therapy alone for 14 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Curcumin

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Omar El Rakabawy

Teaching Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Demerdash Hospital, Faculty of Medicine, Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

RHDIRB2020110301 REC#120

Identifier Type: -

Identifier Source: org_study_id