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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000075
• Date of registration: 13/03/2009
• Primary sponsor: Center of Pharmaceutical Chemistry
• Public title: Clinical evaluation of the effect anti-inflammatory of the extract of Mangifera indica L. (Vimang®) in patients with diagnosis of Bronchial Asthma
• Scientific title: Clinical evaluation of the effect anti-inflammatory of the extract of Mangifera indica L. (Vimang®) in patient with diagnosis of Bronchial Asthma.
• Date of first enrolment: 25/03/2009
• Target sample size: 88
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000075-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr. Alina Alvarez-Leon
• Affiliation: Center of Pharmaceutical Chemistry

• Name: Dr. Alina Alvarez-Leon
• Affiliation: Center of Pharmaceutical Chemistry

Key inclusion & exclusion criteria

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.

Age minimum: 20 years
Age maximum: 45 years
Gender: Both

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.

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.

Secondary Outcome(s)

- 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.

Source(s) of Monetary Support

Ministry of Public Health and Medical Pharmaceutical Industry