NCT07149961

Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Universitas Diponegoro · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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	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).

Timeline

• Start date: 2025-02-05
• Primary completion: 2025-04-25
• Completion: 2025-05-20
• First posted: 2025-09-02
• Last updated: 2025-09-02

Locations

1 site across 1 country: Indonesia