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ST Elevation Myocardial Infarction (STEMI)SPICE STEMINCT07149961

Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial

A study testing Curcumin plus Piperine in people with ST Elevation Myocardial Infarction (STEMI) and Malondialdehyde, run by Universitas Diponegoro at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Curcumin plus Piperine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteIndonesia
Study dates
5 Feb 2025to 20 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Universitas Diponegoro

    Semarang, Central Java, 50275

Other trials in Indonesia

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Curcumin plus Piperine, Placebo capsules
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
Medical subject headings
ST Elevation Myocardial Infarction, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Curcumin plus PiperineDietary supplement

    Also called Curcuma Xanthorrhiza with Piper Nigrum, Turmeric Extract with 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.

  • Placebo capsulesOther

    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).

Study groups in NCT07149961
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants 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.
Receives: Other: Placebo capsules
Curcumin-Piperine SupplementationExperimentalParticipants 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.
Receives: Dietary Supplement: Curcumin plus Piperine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (pre-intervention), within 48-72 hours post-PPCI and after 28 days of intervention

  2. 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.

    Measured: Baseline (pre-intervention), within 48-72 hours post-PPCI and after 28 days of intervention

Secondary outcomes (3)

  1. Liver Function

    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.

    Measured: Baseline and after 28 days of intervention

  2. Change in Serum Creatinine Levels

    Serum creatinine will be measured to evaluate kidney function at baseline and after 28 days of supplementation. Unit of Measure: mg/dL.

    Measured: Baseline and after day 28 of intervention

  3. Change in Estimated Glomerular Filtration Rate (eGFR)

    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.

    Measured: Baseline and after day 28 of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2025
  2. Study start5 Feb 2025
  3. Primary completion25 Apr 2025
  4. Study completion20 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07149961
Sponsor's protocol ID
984/UN7.F4/PP/II/2025
Other IDs
984/UN7.F4/PP/II/2025
Acronym
SPICE STEMI
Status last verified
Aug 2025
First submitted
16 Aug 2025
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The IPD will not be made publicly available due to ethical restrictions and confidentiality agreements with participants, as approved by the institutional review board.

Publications

  • Lao CD, Ruffin MT 4th, Normolle D, Heath DD, Murray SI, Bailey JM, Boggs ME, Crowell J, Rock CL, Brenner DE. Dose escalation of a curcuminoid formulation. BMC Complement Altern Med. 2006 Mar 17;6:10. doi: 10.1186/1472-6882-6-10.

    PubMed 16545122

  • Soni KB, Kuttan R. Effect of oral curcumin administration on serum peroxides and cholesterol levels in human volunteers. Indian J Physiol Pharmacol. 1992 Oct;36(4):273-5.

    PubMed 1291482

  • Shacham Y, Leshem-Rubinow E, Gal-Oz A, Ben-Assa E, Steinvil A, Keren G, Roth A, Arbel Y. Relation of in-hospital serum creatinine change patterns and outcomes among ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. Clin Cardiol. 2015 May;38(5):274-9. doi: 10.1002/clc.22384. Epub 2015 Feb 1.

    PubMed 25639761

  • Trujillo J, Chirino YI, Molina-Jijon E, Anderica-Romero AC, Tapia E, Pedraza-Chaverri J. Renoprotective effect of the antioxidant curcumin: Recent findings. Redox Biol. 2013 Sep 17;1(1):448-56. doi: 10.1016/j.redox.2013.09.003.

    PubMed 24191240

  • Shoskes D, Lapierre C, Cruz-Correa M, Muruve N, Rosario R, Fromkin B, Braun M, Copley J. Beneficial effects of the bioflavonoids curcumin and quercetin on early function in cadaveric renal transplantation: a randomized placebo controlled trial. Transplantation. 2005 Dec 15;80(11):1556-9. doi: 10.1097/01.tp.0000183290.64309.21.

    PubMed 16371925

  • Albert MA, Staggers J, Chew P, Ridker PM; PRINCE Investigators. The pravastatin inflammation CRP evaluation (PRINCE): rationale and design. Am Heart J. 2001 Jun;141(6):893-8. doi: 10.1067/mhj.2001.115297.

    PubMed 11376301

  • Wongcharoen W, Jai-Aue S, Phrommintikul A, Nawarawong W, Woragidpoonpol S, Tepsuwan T, Sukonthasarn A, Apaijai N, Chattipakorn N. Effects of curcuminoids on frequency of acute myocardial infarction after coronary artery bypass grafting. Am J Cardiol. 2012 Jul 1;110(1):40-4. doi: 10.1016/j.amjcard.2012.02.043. Epub 2012 Apr 3.

    PubMed 22481014

  • Boshagh K, Khorvash F, Sahebkar A, Majeed M, Bahreini N, Askari G, Bagherniya M. The effects of curcumin-piperine supplementation on inflammatory, oxidative stress and metabolic indices in patients with ischemic stroke in the rehabilitation phase: a randomized controlled trial. Nutr J. 2023 Dec 11;22(1):69. doi: 10.1186/s12937-023-00905-1.

    PubMed 38082237

  • Panahi Y, Hosseini MS, Khalili N, Naimi E, Majeed M, Sahebkar A. Antioxidant and anti-inflammatory effects of curcuminoid-piperine combination in subjects with metabolic syndrome: A randomized controlled trial and an updated meta-analysis. Clin Nutr. 2015 Dec;34(6):1101-8. doi: 10.1016/j.clnu.2014.12.019. Epub 2015 Jan 7.

    PubMed 25618800

  • El-Saadony MT, Yang T, Korma SA, Sitohy M, Abd El-Mageed TA, Selim S, Al Jaouni SK, Salem HM, Mahmmod Y, Soliman SM, Mo'men SAA, Mosa WFA, El-Wafai NA, Abou-Aly HE, Sitohy B, Abd El-Hack ME, El-Tarabily KA, Saad AM. Impacts of turmeric and its principal bioactive curcumin on human health: Pharmaceutical, medicinal, and food applications: A comprehensive review. Front Nutr. 2023 Jan 10;9:1040259. doi: 10.3389/fnut.2022.1040259. eCollection 2022.

    PubMed 36712505

  • Singgih Wahono C, Diah Setyorini C, Kalim H, Nurdiana N, Handono K. Effect of Curcuma xanthorrhiza Supplementation on Systemic Lupus Erythematosus Patients with Hypovitamin D Which Were Given Vitamin D3 towards Disease Activity (SLEDAI), IL-6, and TGF-beta1 Serum. Int J Rheumatol. 2017;2017:7687053. doi: 10.1155/2017/7687053. Epub 2017 Dec 28.

    PubMed 29445400

  • Cai X, Fang Z, Dou J, Yu A, Zhai G. Bioavailability of quercetin: problems and promises. Curr Med Chem. 2013;20(20):2572-82. doi: 10.2174/09298673113209990120.

    PubMed 23514412

  • Pizzino G, Irrera N, Cucinotta M, Pallio G, Mannino F, Arcoraci V, Squadrito F, Altavilla D, Bitto A. Oxidative Stress: Harms and Benefits for Human Health. Oxid Med Cell Longev. 2017;2017:8416763. doi: 10.1155/2017/8416763. Epub 2017 Jul 27.

    PubMed 28819546

  • Moller P, Wallin H, Knudsen LE. Oxidative stress associated with exercise, psychological stress and life-style factors. Chem Biol Interact. 1996 Sep 27;102(1):17-36. doi: 10.1016/0009-2797(96)03729-5.

    PubMed 8827060

  • Shoba G, Joy D, Joseph T, Majeed M, Rajendran R, Srinivas PS. Influence of piperine on the pharmacokinetics of curcumin in animals and human volunteers. Planta Med. 1998 May;64(4):353-6. doi: 10.1055/s-2006-957450.

    PubMed 9619120

Questions about this trial

What is this clinical trial studying?

A study testing Curcumin plus Piperine in people with ST Elevation Myocardial Infarction (STEMI) and Malondialdehyde, run by Universitas Diponegoro at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07149961, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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