Anxiety Control by Erythrina Mulungu

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EstadoTerminado

Patrocinadores

Liane Maciel de Almeida Souza

Colaboradores

University of Campinas, Brazil

ENSAYO CLÍNICO: NCT01948622

BioSeek: NCT01948622

Palabras clave

Abstracto

This study evaluated the effectiveness of the Erythrina mulungu in controlling anxiety in patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.

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

Dental Anxiety

Impacted Third Molar Tooth

Intervención / tratamiento

Drug: Mulungu

Drug: placebo

Fase

Fase 1/Fase 2

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]

Changes in the subjects' anxiety level was observed by using a Modified Corah Dental Anxiety Scale in three times: at baseline, in the day of surgery and after 7 days of the procedure.

Medidas de resultado secundarias

1. Changes in blood pressure [Change from baseline to 2 hours]

blood pressure (mmHg) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.

2. Changes in heart rate [Change from baseline to 2 hours]

heart rate (bpm) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.

3. Changes in oxygen saturation [Change from baseline to 2 hours]

oxygen saturation (SpO2) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.