Clinical trial NCT01948622: Anxiety Control by Erythrina Mulungu
Official title: Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dental Anxiety
Impacted Third Molar Tooth
Keywords: Anxiety
Third molar surgery
Blood pressure
Heart rate
Oxygen saturation
Lead sponsor: Universidade Federal de Sergipe
Sponsor class: OTHER
Collaborators: name: University of Campinas, Brazil
First posted: 2013-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: : 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%.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in anxiety report
timeFrame: Change from baseline to 7 days
Secondary outcomes:
measure: Changes in blood pressure
timeFrame: Change from baseline to 2 hours
measure: Changes in heart rate
timeFrame: Change from baseline to 2 hours
measure: Changes in oxygen saturation
timeFrame: Change from baseline to 2 hours
Other outcomes:
Locations:
city: Aracaju
country: Brazil
facility: Federal University of Sergipe
state: Sergipe
Study officials:
affiliation: Federal University of Sergipe
name: Liane M Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balbani AP, Silva DH, Montovani JC. Patents of drugs extracted from Brazilian medicinal plants. Expert Opin Ther Pat. 2009 Apr;19(4):461-73. doi: 10.1517/13543770902824180.
citation: Flausino OA Jr, Pereira AM, da Silva Bolzani V, Nunes-de-Souza RL. Effects of erythrinian alkaloids isolated from Erythrina mulungu (Papilionaceae) in mice submitted to animal models of anxiety. Biol Pharm Bull. 2007 Feb;30(2):375-8. doi: 10.1248/bpb.30.375.
citation: Flausino O Jr, Santos Lde A, Verli H, Pereira AM, Bolzani Vda S, Nunes-de-Souza RL. Anxiolytic effects of erythrinian alkaloids from Erythrina mulungu. J Nat Prod. 2007 Jan;70(1):48-53. doi: 10.1021/np060254j.
citation: Onusic GM, Nogueira RL, Pereira AM, Flausino Junior OA, Viana Mde B. Effects of chronic treatment with a water-alcohol extract from Erythrina mulungu on anxiety-related responses in rats. Biol Pharm Bull. 2003 Nov;26(11):1538-42. doi: 10.1248/bpb.26.1538.