Policosanol for long term-Ictus
Phase 4
- Conditions
- ischaemic stroke
- Registration Number
- RPCEC00000169
- Lead Sponsor
- Center of Natural Products/National Center for Scientific Researchs
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. Documented history of TIA or stroke in the previous 3 months (diagnosed in 30 days)
2. Who agree to participate
3. Rankin scale values ??of 2 to 5
4. No exclusion criteria
Exclusion Criteria
1. Neoplasms diagnosed
2. Atrial fibrillation
3. Hipertenmsión diastolic <= 110 mm Hg
4. History of hemorrhagic stroke or subarachnoid hemorrhage
5. Heart Valves
6. IMA background, unstable angina or revasculariación in 6 months
7. Any special condition to the doctor that jeopardize their health and their lives during the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eurological deficit (Modified Rankin Scale. 0-No symptoms, 1-symptoms but able to perform all usual activities, 2-mild disability but able to carry out activities without assistance, 3-moderate disability requiring some help but able to walk unassisted, 4-moderately severe disability, 5 severe disability, bedridden, incontinent, and requires nursing care and constant attention). Measuring time: at baseline, at 6,12,18, 24,32, 40 and 48 weeks.
- Secondary Outcome Measures
Name Time Method eurological deficit (Barthel scale. <45 - severe, Grave 45-59, 60-80 Moderate light 80-100). Measuring time: at baseline, at 6,12,18, 24,32, 40 and 48 weeks.<br>Blood biochemical parameters (Total cholesterol (mmol / L), LDL-C (mmol / L), HDL-C (mmol / L), ALT (U/L), AST(U/L), Glucosa (mmol/L), creatinina (umol/L), GGT (U/L)). Measuring time: at baseline, at 12, 24 and 48 weeks.<br>Physical Assessment (Body weight (kg), frequency (beats / min), blood pressure (mm Hg)). Measuring time: at baseline, at 6, 12, 18, ??24, 32, 40 and 48 weeks.<br>Adverse events (description (name of the event), intensity (mild-moderate, severe), causality (definitely related, probably related, possibly related, not related)).Measuring time: at baseline, at 6, 12, 18, ??24, 32, 40 and 48 weeks.