Anxiety Control by Erythrina Mulungu

Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction

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

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Impacted Third Molar Tooth
• Intervention / Treatment: Drug: Mulungu; Drug: Placebo

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%.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Sergipe
    • Aracaju, Sergipe, Brazil, 49060-100
      • Federal University of Sergipe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Other Names: Mulungu Matusa, Erytrina mulungu
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in anxiety report	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.	Change from baseline to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood pressure	blood pressure (mmHg) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.	Change from baseline to 2 hours
Changes in heart rate	heart rate (bpm) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.	Change from baseline to 2 hours
Changes in oxygen saturation	oxygen saturation (SpO2) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.	Change from baseline to 2 hours

Collaborators and Investigators

• Sponsor: Liane Maciel de Almeida Souza
• Collaborators: University of Campinas, Brazil
• Investigators: Principal Investigator: Liane M Souza, PhD, Federal University of Sergipe

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 23, 2013

Study Record Updates

• Last Update Posted (Estimate): September 23, 2013
• Last Update Submitted That Met QC Criteria: September 18, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Anxiety; Blood pressure; Heart rate; Oxygen saturation; Third molar surgery
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Mulungu-401-2011