Extract of Mangifera indica L. (Vimang®)-Ischemic Stroke

Phase 2

• Conditions: Ischemic stroke; Oxidative Stress; Stroke; Cerebral Infarction; Brain Infarction; Brain Ischemia; Brain Diseases; Vascular Diseases; Nervous System Diseases; Stress, Physiological

• Registration Number: RPCEC00000004
• Lead Sponsor: Center of Pharmaceutical Chemistry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patient of any sex and race.
2. Patient older than 41 years.
3. Patient with ischemic stroke of any localization, with less than 12 hours of evolution of the stroke.
4. Patient that Computer Axial Tomography by Perfusion is carried out before the 12 hours of initiate the stroke.
5. Participation consent in the study.

Exclusion Criteria

1.Coma ( Glasgow scale smaller than 8).
2. Hemorrhage cerebrum-vascular illness or skull trauma in the last three months.
3.Patient with symptoms or neurological signs that they return to the normality before the beginning of the treatment.
4. Suspicions of vascular inflammatory illnesses as cause of the current ischemic stroke (lupus and other illnesses of the colagen).
5. Hypersensibility to the aspirin or iodine.
6. Pregnancy or nursing
7. Patient that receive treatment with another antioxidants, some anticoagulant or neuroprotector drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main variable of answer will be the clinical evaluation according to the scale of NIHSS. This it will be measured to the beginning, to the 3 months and 6 months.

Secondary Outcome Measures

Name	Time	Method
Decrease of the area of dimness regarding the initial mensuration. It will be measured to the beginning and the 7 days. Parameters of oxidative strees. Global indicator: Potential of Peroxidation (PP): Value of reference: 7,32 - 0,56 Other variables: Enzymes: Superoxide dismutasa (SOD): value of reference: 1,45+ - 0,15 Catalasa (CAT): value of reference: 161,5+ - 12,5 CAT/SOD: value of reference: 0,11+ - 0,02 Biomolecular damage: value of reference: 1,45+ - 0,15 total Hydroperoxids: value of reference: 1,74+ - 0,27 advanced products of the oxidation of proteins : value of reference: 12,13+ - 0,93. In leukocytes: Fragmentation of the DNA Antioxidants of low molecular weight: Reduced Glutation : value of reference: 786 - 1156. Quality of life: Modified Scale of Rankin. All these variables will be measured to the beginning, 3 months and 6 months.