Anxiety Control by Erythrina Mulungu
Palabras clave
Abstracto
Descripción
: In this research, characterized as a randomized, double-blind, crossover study, 30 healthy volunteered patients (05 men and 25 women) aged 18 or older who received a capsule of 500mg of Mulungu Matusa ® or placebo, orally, one hour before the procedure were selected. The level of anxiety was assessed through questionnaires and physical parameters, such as blood pressure, heart rate and oxygen concentration. Data were collected, tabulated and analyzed by the following statistical tests: chi-square, t-test, ANOVA and Tukey test, Friedman, Fisher's exact test with significance level of 5%.
fechas
Verificado por última vez: | 08/31/2013 |
Primero enviado: | 09/09/2013 |
Inscripción estimada enviada: | 09/17/2013 |
Publicado por primera vez: | 09/22/2013 |
Última actualización enviada: | 09/17/2013 |
Última actualización publicada: | 09/22/2013 |
Fecha de inicio real del estudio: | 12/31/2011 |
Fecha estimada de finalización primaria: | 05/31/2012 |
Fecha estimada de finalización del estudio: | 10/31/2012 |
Condición o enfermedad
Intervención / tratamiento
Drug: Mulungu
Drug: placebo
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Active Comparator: Mulungu 500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) administered v.o., one hour before the surgical procedure. | Drug: Mulungu 500 mg/single dose/1 hour before dental surgery |
Placebo Comparator: placebo 500 mg of starch (2 capsules of 250 mg) administered v.o., one hour before the surgical procedure. | Drug: placebo 500 mg/single dose/1 hour before dental surgery |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - indication of bilateral extraction of asymptomatic, impacted mandibular third molars Exclusion Criteria: - patients under the age of 18 - any general health problem based on the medical history and physical examination - history of use of any medication within 15 days before the beginning of the research - history of hypersensitivity to drugs, substances or materials used in this experiment - pregnancy or lactation - history of pericoronitis |
Salir
Medidas de resultado primarias
1. Changes in anxiety report [Change from baseline to 7 days]
Medidas de resultado secundarias
1. Changes in blood pressure [Change from baseline to 2 hours]
2. Changes in heart rate [Change from baseline to 2 hours]
3. Changes in oxygen saturation [Change from baseline to 2 hours]