Anxiety Control by Erythrina Mulungu

Dental Anxiety Clinical Trial

Official title:

Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948622
• Other study ID #: Mulungu-401-2011
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 10, 2013
• Last updated: September 18, 2013
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: September 2013
• Source: Universidade Federal de Sergipe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety
• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

Drug:
• Mulungu
500 mg/single dose/1 hour before dental surgery
• Placebo
500 mg/single dose/1 hour before dental surgery

Locations

Country	Name	City	State
Brazil	Federal University of Sergipe	Aracaju	Sergipe

Sponsors (2)

Lead Sponsor	Collaborator
Liane Maciel de Almeida Souza	University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. Review. — View 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. — View 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. — View Citation

Onusic GM, Nogueira RL, Pereira AM, Flausino Júnior 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No