Policosanol in patients with metabolic syndrome and ischaemic cardiopaty

Median term study of the effects of Policosanol in patients with metabolic syndrome and ischaemic cardiopathy - Poli/Pla-SM-CI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000227

Enrollment

100

Registered

2016-12-27

Start date

2017-01-15

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

Metabolic Syndrome and ischaemic cardiopaty

Interventions

Group 1 (Experimental): 1 tablet of policosanol (10 mg) by oral administration, one daily with food for 6 months. Group 2 (Control): 1 tablet of placebo by oral administration, once daily with food

Anticholesteremic Agents

Hypolipidemic Agents

Platelet Aggregation Inhibitors

Antioxidants

Fatty Alcohols

Administration, Oral

Placebos

Tablets

Policosanol

Eligibility

Sex/Gender

All

Age

25 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Patients with ischaemic cardiopaty. 2) Both sexes. 3) Age: 25-70 years 4) Diagnostic of metabolic syndrome by NCEP-ATP III criteria

Exclusion criteria

Exclusion criteria: 1) Consuming policosanol or other lipid lowering drug and antioxidant or pro-oxidant medications, six months period previus study. 2) Ischaemic or haemorragic ictus. 3) Mayor surgery six mionths previusat study begining. 4) Cardiac insuficience. 5) Hepatic insuficience. 6) Neoplasms diagnosed. 7) Alcoholism. 8) Psyquiatric problems. 9) Patients with clinical history of allergy to any other medicines or other conditions that endanger their health and their lives during the study.

Design outcomes

Primary

Measure	Time frame
Oxidative stress and antioxidant defenses determination: Concentration of Maolondialdehido (MDA) (uM). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of advances products of the oxidation of proteins (PAOP) (uM cloramine). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of total organoperoxides (OT) (uM). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of glutation (GSH) (mg L). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of superoxid dismutase (SOD) (U mL min). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of catalase (CAT) (uM). Measuring time: at baseline, 90 and 180 days of treatment.	—

Measure

Time frame

Oxidative stress and antioxidant defenses determination: Concentration of Maolondialdehido (MDA) (uM). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of advances products of the oxidation of proteins (PAOP) (uM cloramine). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of total organoperoxides (OT) (uM). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of glutation (GSH) (mg L). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of superoxid dismutase (SOD) (U mL min). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of catalase (CAT) (uM). Measuring time: at baseline, 90 and 180 days of treatment.

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Secondary

Measure	Time frame
Tryglicerides (mmol/L), HDL-C (mmol/L). Measuring time: at baseline, 90 and 180 days of treatment. Risk stratification by total score of Goldman Scale. Measuring time: At baseline, 90 and 180 days of treatment. Physical status (weight (kg), rate (beats/min), blood pressure (mm Hg)). Measuring time: At baseline, 45, 90, 135 and 180 days of treatment. Laboratory parameters: cholesterol (mmol/L), LDL-C (mmol/L), alcaline phosphatase /U/L), glucose (mmol/L), creatinine (umol/L), ALT (U/L), AST (U/L), total protein (g/L), albumin (g/L), uric acid (mmol/L), urea (mmol/L), apo A (g/L9, apo B (g/L). Measuring time: At baseline, 45, 90, 135 and 180 days of treatment. Adverse Events-AE (Description (AE name), intensity (mild, moderate, severe), causality (definitely related, probably related, possibly related, unrelated)). Measuring time: At the end of 45, 90, 135 and 180 days of treatment.	—

Measure

Time frame

Tryglicerides (mmol/L), HDL-C (mmol/L). Measuring time: at baseline, 90 and 180 days of treatment. Risk stratification by total score of Goldman Scale. Measuring time: At baseline, 90 and 180 days of treatment. Physical status (weight (kg), rate (beats/min), blood pressure (mm Hg)). Measuring time: At baseline, 45, 90, 135 and 180 days of treatment. Laboratory parameters: cholesterol (mmol/L), LDL-C (mmol/L), alcaline phosphatase /U/L), glucose (mmol/L), creatinine (umol/L), ALT (U/L), AST (U/L), total protein (g/L), albumin (g/L), uric acid (mmol/L), urea (mmol/L), apo A (g/L9, apo B (g/L). Measuring time: At baseline, 45, 90, 135 and 180 days of treatment. Adverse Events-AE (Description (AE name), intensity (mild, moderate, severe), causality (definitely related, probably related, possibly related, unrelated)). Measuring time: At the end of 45, 90, 135 and 180 days of treatment.

—

Countries

Cuba

Contacts

Public ContactJulio Fernandez Travieso

Center of Natural Products, National Center for Scientific Research

julio.fernandez@cnic.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026