Clinical evaluation of the effect anti-inflammatory of the extract of Mangifera indica L. (Vimang®) in patients with diagnosis of Bronchial Asthma

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:

Clinical evaluation of the effect anti-inflammatory of the extract of Mangifera indica L. (Vimang®) in patient with diagnosis of Bronchial Asthma.

Source(s) of monetary or material support:

Ministry of Public Health and Medical Pharmaceutical Industry

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 :

24/12/2008

Reference number:

Volume 06 Folio 000329. 3127-0501207 N

Principal investigator

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

First name:

Dr. Alfredo Jane-Lara. Specialist of 1er degree in Internal Medicine, Specialist of 2do degree in Pneumology

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

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, Surgical Research Medical Center, Dr. Marlen Izquierdo-Gonzalez, Specialist of 2do degree in Internal Medicine, Specialist of 1er degree in Integral General Medicine.

Research ethics committees:

Ethics Committe of the 43 Clinic, date of approval 19 of June of 2007 Ethics Committe of the Surgical Research Medical Center , date of approval 29 of June of 2007.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

25/03/2009

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:

Bronchial Asthma

Intervention(s):

Will be designed two treatment groups. Group I: The patients will receive treatment with Vimang®, pills of 600mg, oral way, two pills every 12 hours, plus the specific therapy. Group II: The patients will receive treatment with placebo, plus the specific therapy. The treatments will be applied during 3 months, time limit of duration of the clinical trial.

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 is the degree of bronchial obstruction according to the FEV1. It will consider positive answer when the predictive % of FEV1, with regard to the value initial pre or post bronchial dilator, improves even when the relationship FEV1/FVC (FEV1%) doesn't improve. This variable will be measured to the beginning, month and half and three months of treatment.

Key secondary outcomes:

- Clinical improvement 1. The spacing of the day symptoms, dyspnea, thoracic oppression, sibilance. 2. The spacing of the night symptoms (cough, sibilance). - Improvement of anyone of the spirometrics variables: 1) Forced Vital Capacity (FVC) 2) Flow Forced Expriring Flow (FEF) among the 25 to 75% of FVC(FEF25-75) 3) Instantaneous Forced Expiring Flow in 50% of the FVC (FEF50) 4) Maximun Expiring Flow Pick FEFmax (PEF) 5) FEV1/FVC (FEV1%) IgE serum concentrations and the levels of cationic protein of the eosinophile cell, as biological marker of inflammation, decrease. These variables will be measured to the beginning, month and half and three months of treatment.

Selection criterias

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

Gender:

Male/Female

Minimum age:

20 years

Maximum age:

45 years

Inclusion criteria:

-Patients of both sexes, between 20 and 45 years of age, non smokers, who are attended in ambulatory clinics, with diagnosis of persistent moderate asthma that they will be classified by the obstruction degree by spirometry according to Gina 2006. -Patient that are of agreement with participating in the clinical trial -Patients have carried out a Respiratory Functional Test (RFT) with test pre and post bronchial dilator before beginning to take the Vimang® and that it expresses a limitation to the air, reversible or partially reversible flow with bronchial dilator(inhaled Salbutamol).

Exclusion criteria:

- Smoking Patients. - Pregnancy or nursing. - Patients that have normal RFT. - Patient without antecedents of bronchial asthma. - The patient's negative to fulfill the established dose of the Vimang®. - The patient's negative to carry out the protocolized investigations. - Patient that not fulfill with the measures of systematic control: weekly phone calls that include the control of the asthma, besides the biweekly consultation.

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:

Target sample size:

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. Alina

Last Name:

Alvarez-Leon

Affiliation:

Center of Pharmaceutical Chemistry

Postal Address:

21 Ave. and 200 St., Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 271 5067

Email :

alina.alvarez@infomed.sld.cu [2]

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. Alina

Last Name:

Alvarez-Leon

Affiliation:

Center of Pharmaceutical Chemistry

Postal Address:

21 Ave. and 200 St., Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 271 5067

Email :

alina.alvarez@infomed.sld.cu [2]

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:

RPCEC00000075

Date of Registration in Primary Registry:

2009-03-13

Record Verification Date:

2009-03-03 19:00

Link to the spanish version:

Click here [3]