Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-02-08 @ 2:27 PM
Study NCT ID:
NCT07149961
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2025-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial
Sponsor:
Universitas Diponegoro
Organization:
Study Overview
Official Title:
Supplementation of Piperine and Curcumin (Curcuma Xanthorrhiza) Extract in ST Elevation Myocardial Infarction - SPICE STEMI Trial
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPICE STEMI
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 984/UN7.F4/PP/II/2025 | OTHER_GRANT | Universitas Diponegoro | View |