Diabetes Mellitus, Type 2Phase 2NCT05753436
Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk
A Phase 2 study testing Puritans Pride Turmeric curcumin® 500 mg in people with Diabetes Mellitus, Type 2 and Dyslipidemias, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension
- What is being tested?
- Puritans Pride Turmeric curcumin® 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Puritans Pride Turmeric curcumin® 500 mg
- Keywords
- Diabetes Mellitus, ASCVD Risk, Curcumin, Inflammation, Oxidative stress, Diabetes complication
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension, Diabetes Mellitus, Inflammation, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puritans Pride Turmeric curcumin® 500 mgDietary supplement
Also called Curcumin
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1, Curcumin group | Active comparator | Group 1, Curcumin group (n=36): Patients will receive conventional treatment co-administrated with Turmeric Curcumin 500 mg thrice daily for 14 weeks. Receives: Dietary Supplement: Puritans Pride Turmeric curcumin® 500 mg |
| Group 2, Control group | No intervention | Group 2, Control group (n= 36): Patients will receive conventional therapy alone for 14 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Atherosclerotic cardiovascular diseases risk score) Low-risk (<5%) Borderline risk (5% to 7.4%) Intermediate risk (7.5% to 19.9%) High risk (≥20%)
10 year ASCVD risk calculation by using Pooled cohort equations
Measured: Change from Baseline ASCVD risk scoring at 14 weeks
Blood Glucose Level
Fasting blood glucose (FBG) in mg/dl , Hemoglobin A1c (HbA1c) in percentage
Measured: Change from Baseline Blood Glucose Level at 14 weeks
Lipid Profile
Serum sample to determine ( Triglyceride level , LDL ,HDL ,Total cholesterol ) in mg/dl
Measured: Change from Baseline Lipid profile at 14 weeks
Blood Pressure
(SBP and DBP) in mmHg by using Sphygmomanometer
Measured: Change from Baseline Blood Pressure at 14 weeks
Heart Rate
Pulse in bpm
Measured: Change from Baseline Heart Rate at 14 weeks
Secondary outcomes (4)
Concentration of Tumor necrosis factor alpha ( TNF-alpha)
Serum sample to determine TNF alpha (Inflammatory biomarker)
Measured: Change from Baseline TNF-alpha concentration at 14 weeks
Concentration of Malondialdehyde (MDA)
Serum sample to determine MDA (Oxidative stress marker)
Measured: Change from Baseline MDA concentration at 14 weeks
International normalized ratio
Blood sample to determine INR level for those patients receiving anticoagulants
Measured: Change from Baseline INR level at 14 weeks
Serum Ferritin
Serum Ferritin for those patients who are suspected to be anemic or are anemic.
Measured: Change from Baseline Ferritin concentration at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Jul 2023
- Primary completion1 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar El Rakabawy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753436
- Sponsor's protocol ID
- RHDIRB2020110301 REC#120
- Status last verified
- Aug 2025
- First submitted
- 31 Jan 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Curcumin Administration on the Clinical Outcome of Diabetic Patients With Atherosclerotic Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT05753436
- Acronym / sponsor ID
- RHDIRB2020110301 REC#120
- Conditions
- Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension
- Keywords
- Diabetes Mellitus, ASCVD Risk, Curcumin, Inflammation, Oxidative stress, Diabetes complication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, Curcumin group | Active comparator | Dietary Supplement: Puritans Pride Turmeric curcumin® 500 mgGroup 1, Curcumin group (n=36): Patients will receive conventional treatment co-administrated with Turmeric Curcumin 500 mg thrice daily for 14 weeks. |
| Group 2, Control group | No intervention | –Group 2, Control group (n= 36): Patients will receive conventional therapy alone for 14 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Puritans Pride Turmeric curcumin® 500 mgAlso: CurcuminTurmeric 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. | Dietary supplement | Group 1, Curcumin group |
Primary outcome
(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
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
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
Blood Pressure
Time frame: Change from Baseline Blood Pressure at 14 weeks
(SBP and DBP) in mmHg by using Sphygmomanometer
Heart Rate
Time frame: Change from Baseline Heart Rate at 14 weeks
Pulse in bpm
4 secondary outcomes
Concentration of Tumor necrosis factor alpha ( TNF-alpha)
Time frame: Change from Baseline TNF-alpha concentration at 14 weeks
Concentration of Malondialdehyde (MDA)
Time frame: Change from Baseline MDA concentration at 14 weeks
International normalized ratio
Time frame: Change from Baseline INR level at 14 weeks
Serum Ferritin
Time frame: Change from Baseline Ferritin concentration at 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Puritans Pride Turmeric curcumin® 500 mg in people with Diabetes Mellitus, Type 2 and Dyslipidemias, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.