Revisions for Extract of Mangifera indica L. (Vimang®)-Ischemic Stroke | Registro Público Cubano de Ensayos Clínicos

Comparing two revisions:

--- 1 November 2016 - 2:30pm by lazara
+++ 20 January 2017 - 12:23pm by lazara
-La Habana, Hospital Dr. C. J. Finlay, Dra. Tania Arrieta Hernández, 1st Grade Specialist in Neurology
-Not limit
+None
-/11/01
+/01/20
-/11/01
+/01/20

Revision of 20 January 2017 - 12:23pm:

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

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 effect of an extract of Mangifera indica L. (Vimang®) in patient with Ischemic stroke.

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Ministry of Public Health Ministry of Science, Technology and Environment

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 :

29/11/2004

Reference number:

05-020-04-N

Principal investigator

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

First name:

Tania

Last name:

Arrieta-Hernandez

Medical Specialty :

1st Grade Specialist in Neurology

Affiliation:

Hospital Dr. C. J. Finlay

Postal address:

Calle 114 y ave 31. Marianao.

City:

La Habana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72748531

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

Research ethics committees:

Ethics Committe of Dr. Carlos J. Finlay Hospital. Date: May 17, 2004.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

17/03/2008

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:

Ischemic stroke

Health condition(s) code:

Cerebral Infarction

Oxidative Stress

Brain Infarction

Brain Ischemia

Stroke

Cerebrovascular Disorders

Brain Diseases

Vascular Diseases

Central Nervous System Diseases

Nervous System Diseases

Stress, Physiological

Physiological Processes

Intervention(s):

Will be designed two treatment groups, which differed as for the therapy: The first group will receive orally, Vimang® 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.

Intervention code:

Mangifera indica

Aspirin

Antioxidants

Anti-Inflammatory Agents

Tablets

Administration, Oral

Placebos

Intervention keyword:

Vimang®

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):

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.

Key secondary outcomes:

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.

Selection criterias

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

Gender:

Male/Female

Minimum age:

41 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

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

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

120

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:

Mariela

Middle Name:

Margarita

Last Name:

Guevara-Garcia

Specialty:

1st Degree Specialist in Pharmacology

Affiliation:

Center of Pharmaceutical Chemistry

Postal Address:

21 Ave. and 200St., Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 271 5067

Email :

marielaguevara@infomed.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:

Tania

Last Name:

Arrieta-Hernandez

Specialty:

1st Grade Specialist in Neurology

Affiliation:

Dr. Carlos J Finlay Hospital

Postal Address:

114 St and 31 Av., Marianao

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 274 8531

Email :

email@not.entered

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:

RPCEC00000004

Date of Registration in Primary Registry:

2009-03-13

Record Verification Date:

2017/01/20

Next update date:

2018/01/20

Link to the spanish version:

Click here

Registered Trials

Registration process

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

About the RPCEC

Useful resources