Extract of Mangifera indica L. (Vimang®)- Third age- Phase II.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000003
• Date of registration: 27/02/2009
• Primary sponsor: Center of Pharmaceutical Chemistry
• Public title: Extract of Mangifera indica L. (Vimang®)- Third age- Phase II.
• Scientific title: Evaluation of the anti oxidating effect of the extract of Mangifera indica L. in people of the third age.
• Date of first enrolment: 15/11/2007
• Target sample size: 64
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000003-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Other Purpose: Prevention Other design features: None

Countries of recruitment

Cuba

Contacts

• Name: Dr. Annia Riaño-Montalvo
• Affiliation: Center of Pharmaceutical Chemistry

• Name: Dr. Annia Riaño-Montalvo
• Affiliation: Center of Pharmaceutical Chemistry

Key inclusion & exclusion criteria

Inclusion criteria: 1. Persons with 60 year-old or more 2. Written acceptance and voluntary of participating in the clinical trial 3. Good psychological conditions. 4. People that are internal in the Home. 5. Both sexes.
Exclusion criteria: 1. Infection systemic chronicle. 2. Treatment with anti oxidanting in the last month. 3. Current Hyperbaric Oxygenation or in one period of up to 15 days before the moment of their inclusion. 4. Immunosupresive Therapy or steroids therapy in the moment of their inclusion or in the last 3 months. 5. Renal chronicle or failure or hepatical demonstrated clinically. 6. People with cognitive damage. 7. People with dysphagia. 8. People in period of convalescence (up to two weeks) of a sharp infectious illness that could alter the immune answer. 9. Hypersensibility reaction to the components of the formulation.

Age minimum: 60 years
Age maximum: None
Gender: Both

Health Condition(s) or Problem(s) studied

Aging

Intervention(s)

The treatment will be administered orally, according to the following outline: Study Group: 1 pill of Vimang®, 300 mg every 8 hours, one hour before the ingestion of foods, during 6 months to reach a dose daily average of 345 mg of total polifenoles plus the habitual treatment according to the base pathology. Control group. 1 pill of Placebo every 8 hours, of same dose, administration frequency and duration that the study group plus the habitual treatment according to the base pathology.

Primary Outcome(s)

Anti oxidating total (AOT). This variable will be measured to the beginning, 3 months of initiate the treatment and to the 6 months.

Secondary Outcome(s)

Potential peroxidation, reduced, total and oxidated Glutation. Oxidated proteins. Lipid Lipoperoxidation . Catalasa. Dismutasa superoxide, Glutation S - transferasa. Glutation reductasa, Total Hydroperoxides, indicators of quality of life, Filtered glomerular. These variables will be measured to the beginning, 3 months of initiate the treatment and to the 6 months.

Source(s) of Monetary Support

Ministry of Public Health and Medical Pharmaceutical Industry (MINSAP), QUIMEFA