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

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the anti oxidating effect of the extract of Mangifera indica L. in people of the third age.

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

15/03/2007

Reference number:

Volume 06. I folio 000282. 506-05-002-07-N

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Dr.Sofia Valverde-Galiana

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana City, Noemi Deulofeu Home, Dr. Susana Reyes-Almaguer Havana City, Para Empezar a Vivir Home, Dr.Leyanis Reyes-Paredes

Research ethics committees:

Ethics Committee, ad hoc, created with specialists of different institutions that don't belong to the homes that participate in the study. Date: July 20, 2007

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

15/11/2007

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

60 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Other

Other design:

None

Phase:

2

Target sample size:

64

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Dr. Annia

Last Name:

Riaño-Montalvo

Affiliation:

Center of Pharmaceutical Chemistry

Postal Address:

21 Ave. and 200 St., Atabey, Playa.

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

(537) 271 5067

Email :

annia.riano@cqf.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Dr. Annia

Last Name:

Riaño-Montalvo

Affiliation:

Center of Pharmaceutical Chemistry

Postal Address:

21 Ave. and 200 St., Atabey, Playa.

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

(537) 271 5067

Email :

annia.riano@cqf.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000003

Date of Registration in Primary Registry:

2009-02-27

Record Verification Date:

2009-02-11 19:00

Link to the spanish version:

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

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