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

Category Primary study
Registry of TrialsRegistro Público Cubano de Ensayos Clínicos
Year 2009
INTERVENTION: Mangifera indica Vimang(R) Will be designed two treatment groups, which differed as for the therapy: The first group will receive orally, Vimang(R) pills of 300 mg, two pills half hour before the breakfast and two pills half hour before the food during three months, later two pills half hour before the breakfast and a pill half hour before the food until completing six months of treatment. The second group will receive treatment with placebo in the same dose and frequency. All the included patients will receive aspirin, to a dose of 125 mg. daily, more the established symptomatic therapy for the control of the blood pressure, the hyperglucaemia or some other symptomatology that it is presented according to the case, therefore all standardized treatment will be admitted used to achieve this objective. CONDITION: Cerebral Infarction Ischemic stroke PRIMARY OUTCOME: 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: 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. 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.
Epistemonikos ID: 3f08c2e6aa1f33ac2ca2868078de65016cc8fdee
First added on: Aug 22, 2024