Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial

NCT07149961 | Completed DMC

• 1 other identifier: 984/UN7.F4/PP/II/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ST Elevation Myocardial Infarction (STEMI); Malondialdehyde; Hs-CRP; Curcumin; Curcuma Xanthorrhiza; High-sensitivity C-reactive Protein

Keywords

Curcumin; Piperine; Turmeric (Curcuma Xanthorrhiza); Piper nigrum; ST Elevation Myocardial Infarction; Primary Percutaneous Coronary Intervention (PPCI); Oxidative Stress; Inflammation; High-sensitivity C-Reactive Protein; Malondialdehyde; Antioxidants; Anti-Inflammatory Agents

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) at Day 28

  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

  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 Outcomes (3)

• Liver Function

  Baseline and after 28 days of intervention

• Change in Serum Creatinine Levels

  Baseline and after day 28 of intervention

• Change in Estimated Glomerular Filtration Rate (eGFR)

  Baseline and after day 28 of intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Curcumin-Piperine Supplementation

EXPERIMENTAL

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

Interventions

Curcumin plus Piperine DIETARY_SUPPLEMENT

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.

Also known as: Curcuma Xanthorrhiza with Piper Nigrum, Turmeric Extract with Piperine

Curcumin-Piperine Supplementation

Placebo capsules OTHER

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).

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Diponegoro: lead
• Dr. Kariadi Hospital Semarang, indonesia: collaborator

Study Sites (1)

Universitas Diponegoro

Semarang, Central Java, 50275, Indonesia

Location

Related Publications (24)

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Inflammation

Interventions

Curcumin; piperine; turmeric extract

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Fahri Husaini Alkaf, M.D.

  Universitas Diponegoro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcomes assessors are unaware of group allocation. Placebo capsules are identical in appearance, size, and packaging to the curcumin-piperine capsules to maintain blinding. Randomization codes are kept by an independent pharmacist until data analysis is complete. An independent pharmacist and data analyst are also masked to group allocation until database lock. Laboratory personnel performing biomarker analyses (hsCRP and MDA) are blinded to treatment assignment. Randomization codes are securely stored and only accessible to an independent statistician not involved in patient care or outcome assessment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Fahri Husaini Alkaf, M.H.

Model Details: Participants are randomized in a 1:1 ratio to receive either curcumin-piperine supplementation or matching placebo, administered daily for 28 days following primary percutaneous coronary intervention for STEMI. Both groups are followed in parallel for the same duration, with biomarker measurements taken at baseline, 48-72 hours post-procedure, and at day 28.

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: September 2, 2025
• Study Start: February 5, 2025
• Primary Completion: April 25, 2025
• Study Completion: May 20, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)