Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial (SPICE STEMI)

August 24, 2025 updated by: Fahri Husaini Alkaf, Universitas Diponegoro

Supplementation of Piperine and Curcumin (Curcuma Xanthorrhiza) Extract in ST Elevation Myocardial Infarction - SPICE STEMI Trial

This study aims to evaluate whether supplementation with a combination of curcumin and piperine can help reduce inflammation and oxidative stress in patients who have experienced a heart attack called ST-Elevation Myocardial Infarction (STEMI) and are undergoing a procedure known as primary percutaneous coronary intervention (PPCI).

Curcumin, a natural compound from turmeric, is known for its antioxidant and anti-inflammatory effects, but it is not easily absorbed by the body. Piperine, a compound from black pepper, can improve curcumin absorption. By combining the two, we hope to maximize their potential benefits.

The study will measure markers of inflammation (high-sensitivity C-reactive protein, hsCRP) and oxidative stress (malondialdehyde, MDA) at three time points: before treatment, shortly after the PPCI procedure, and after 28 days of supplementation.

The main question is whether curcumin-piperine supplementation can provide additional protection against inflammation and oxidative stress compared to a placebo, potentially supporting recovery and reducing the risk of future heart problems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized, double-blind, placebo-controlled clinical trial investigates the effects of combined curcumin and piperine supplementation on systemic inflammation and oxidative stress in patients with ST-Elevation Myocardial Infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). Curcumin, the principal curcuminoid derived from Curcuma xanthorrhiza or Curcuma longa, has demonstrated anti-inflammatory and antioxidant properties in preclinical and clinical studies. However, its oral bioavailability is limited due to poor absorption and rapid metabolism. Piperine, an alkaloid from Piper nigrum, enhances curcumin's bioavailability through inhibition of hepatic and intestinal glucuronidation.

Participants are randomized to receive either curcumin-piperine supplementation (390 mg curcumin + 20 mg piperine daily) or matched placebo for 28 consecutive days post-PPCI. Biomarkers of inflammation (high-sensitivity C-reactive protein, hsCRP) and oxidative stress (malondialdehyde, MDA) are assessed at three predefined time points: baseline (pre-intervention), 48-72 hours after PPCI, and at day 28 post-supplementation.

The primary objective is to determine whether curcumin-piperine supplementation significantly attenuates the rise in hsCRP and MDA levels compared to placebo. Secondary objectives include evaluating the temporal pattern of biomarker changes and assessing the tolerability and safety profile of the supplementation in the acute and subacute phases post-STEMI. The findings may provide evidence for adjunctive nutraceutical therapy to improve post-MI recovery by targeting inflammatory and oxidative stress pathways.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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

  • Indonesia
    • Central Java
      • Semarang, Central Java, Indonesia, 50275
        • Universitas Diponegoro

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 to 80 years.
  • Confirmed diagnosis of ST-Elevation Myocardial Infarction (STEMI). Symptom onset within 12 hours, or within 12 to 72 hours in cases with an indication for primary percutaneous coronary intervention (PPCI).
  • Receiving standard-of-care medical therapy according to current guidelines, including:

Dual antiplatelet therapy. Angiotensin-Converting Enzyme Inhibitors (ACE-i) or Angiotensin Receptor Blockers (ARBs).

Statins. Beta-blockers.

Exclusion Criteria:

  • Regular prior use of curcumin supplementation.
  • Hemodynamic instability or severe dyspnoea with clinical signs of congestion (elevated jugular venous pressure, pulmonary rales affecting >1/3 of lung fields, hepatomegaly, ascites, or peripheral oedema).
  • History of prior myocardial infarction, previous percutaneous coronary intervention, or coronary artery bypass graft surgery.
  • Known hypersensitivity to curcumin or piperine.
  • Active malignancy.
  • Chronic infections (e.g., hepatitis, tuberculosis, or HIV).
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or rapidly declining renal function.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants receive a matching placebo capsule identical in appearance, size, and packaging to the curcumin-piperine capsule, administered daily for 28 consecutive days following PPCI for STEMI. A loading dose of 2 placebo capsules is administered orally prior to PPCI, followed by maintenance of 1 capsule twice daily until day 28.
Other: Placebo capsules
A loading dose of 2 capsules (each containing saccarum lactic) is administered orally prior to PPCI, followed by maintenance of 1 capsule daily until day 28. Oral administration of standardized placebo capsule, given twice daily for 28 days in addition to standard-of-care therapy for STEMI patients undergoing primary percutaneous coronary intervention (PPCI).
Experimental: Curcumin-Piperine Supplementation
Participants receive curcumin 390 mg combined with piperine 20 mg daily for 28 consecutive days following primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI). A loading dose of 2 capsules (each containing 390 mg curcumin + 20 mg piperine) is administered orally prior to PPCI, followed by maintenance of 1 capsule daily until day 28.
Dietary supplement: Curcumin plus Piperine
A loading dose of 2 capsules (each containing 390 mg curcumin + 20 mg piperine) is administered orally prior to PPCI, followed by maintenance of 1 capsule daily until day 28. Oral administration of standardized curcumin extract (390 mg) combined with piperine (20 mg), given twice daily for 28 days in addition to standard-of-care therapy for STEMI patients undergoing primary percutaneous coronary intervention (PPCI). The curcumin-piperine formulation is used to enhance bioavailability and anti-inflammatory effects, aiming to improve post-MI recovery and reduce oxidative stress.
Other Names:
  • Curcuma Xanthorrhiza with Piper Nigrum
  • Turmeric Extract with Piperine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) at Day 28
Time Frame: Baseline (pre-intervention), within 48-72 hours post-PPCI and after 28 days of intervention
Mean change (Δ) in serum hsCRP from baseline to Day 28, expressed in mg/L. Lower values indicate less systemic inflammation. The prespecified metric is group-wise mean change and between-group difference in mean change.
Baseline (pre-intervention), within 48-72 hours post-PPCI and after 28 days of intervention
Change from Baseline in Malondialdehyde (MDA) at Day 28
Time Frame: Baseline (pre-intervention), within 48-72 hours post-PPCI and after 28 days of intervention
Mean change (Δ) in serum MDA concentration from baseline to Day 28, expressed in nmol/mL. Lower values indicate less lipid peroxidation/oxidative stress. The prespecified metric is group-wise mean change and between-group difference in mean change.
Baseline (pre-intervention), within 48-72 hours post-PPCI and after 28 days of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver Function
Time Frame: Baseline and after 28 days of intervention
To assess changes in liver enzyme activity (ALT and AST) as a marker of hepatic safety and potential hepatoprotective effect of curcumin-piperine supplementation. Unit of Measure: U/L.
Baseline and after 28 days of intervention
Change in Serum Creatinine Levels
Time Frame: Baseline and after day 28 of intervention
Serum creatinine will be measured to evaluate kidney function at baseline and after 28 days of supplementation. Unit of Measure: mg/dL.
Baseline and after day 28 of intervention
Change in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline and after day 28 of intervention
eGFR will be calculated using the CKD-EPI formula to assess kidney function at baseline and after 28 days of supplementation. Unit of Measure: mL/min/1.73 m².
Baseline and after day 28 of intervention

Collaborators and Investigators

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

Sponsor

Universitas Diponegoro

Collaborators

Dr. Kariadi Hospital Semarang, indonesia

Investigators

  • Principal Investigator: Fahri Husaini Alkaf, M.D., Universitas Diponegoro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 5, 2025

Primary Completion (Actual)

April 25, 2025

Study Completion (Actual)

May 20, 2025

Study Registration Dates

First Submitted

August 16, 2025

First Submitted That Met QC Criteria

August 24, 2025

First Posted (Actual)

September 2, 2025

Study Record Updates

Last Update Posted (Actual)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 24, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 984/UN7.F4/PP/II/2025 (Other Grant/Funding Number: Universitas Diponegoro)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will not be made publicly available due to ethical restrictions and confidentiality agreements with participants, as approved by the institutional review board.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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