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The effect of ß-caryophyllene on inflammation in patients with type 2 diabetes and acute coronary syndrome

Evaluation of the effects of ß-caryophyllene on inflammation and insulin resistance in patients with joint Type 2 diabetes mellitus and acute coronary syndrome

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180103038199N20
Enrollment
72
Registered
2026-05-01
Start date
2026-05-22
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: Patients with Type 2 diabetes mellitus and acute coronary syndrome receiving ß-caryophyllene 150 mg once daily for two months along with standard treatment. Both th

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes with a history of acute coronary syndrome according to American College of Heart Disease criteria within the last three months Patients with fasting serum glucose levels greater than or equal to 125 mg/dlPatients with glycosylated hemoglobin blood levels greater than or equal to 6.5% Both male and female gender At least 6 months have passed since the diagnosis of diabetes Age more than 18 years old Consent to admission to the study

Exclusion criteria

Exclusion criteria: Pregnancy Breastfeeding Renal failure and GFR<30 Severe liver failure with liver enzymes three times more than normal Chronic inflammatory disease such as lupus

Design outcomes

Primary

MeasureTime frame
Hs-CRP serum level. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: ELISA reader device.

Secondary

MeasureTime frame
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) level. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Based on the formula for Homeostatic Model Assessment for Insulin Resistance, which is equal to the glucose concentration in millimolar x the insulin concentration in milliinternational units per milliliter (mIU/mL) divided by 22.5.;Triglycerides level. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Autoanalyzer device.;Insulin level. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: ELISA reader device.;Fasting blood sugar level. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Autoanalyzer device.;Hemoglobin A1c levels. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Autoanalyzer with immunoassay method.;Urea level. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Autoanalyzer device.;Creatinine level. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Autoanalyzer device.;Alanine aminotransferase (ALT) level. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Autoanalyzer device.;Aspartate aminotransferase (AST) level. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Autoanalyzer device.;Interleukin-6 (IL-6) level. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: ELISA reader device.;Low-density lipoprotein (LDL) level. Timepoint: Before the start of th

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Vahid Reza Askari

Mashhad University of Medical Sciences

askariv@mums.ac.ir+98 51 3800 2259

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026