Supplementation of Piperine and Curcumin (Curcuma Xanthorrhiza) Extract in ST Elevation Myocardial Infarction - SPICE STEMI Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) at Day 28
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change from Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) at Day 28
时间窗: 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.
Change from Baseline in Malondialdehyde (MDA) at Day 28
时间窗: 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.
次要结局
- 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)
研究者
Fahri Husaini Alkaf
dr. Fahri Husaini Alkaf, M.H.
Universitas Diponegoro