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Anxiety Control by Erythrina Mulungu

NCT ID: NCT01948622

Last Updated: 2013-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-11-30

Brief Summary

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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

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: 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%.

Conditions

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Dental Anxiety Impacted Third Molar Tooth

Keywords

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Anxiety Third molar surgery Blood pressure Heart rate Oxygen saturation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mulungu

500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.

Group Type ACTIVE_COMPARATOR

Mulungu

Intervention Type DRUG

500 mg/single dose/1 hour before dental surgery

placebo

500 mg of starch (2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

500 mg/single dose/1 hour before dental surgery

Interventions

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Mulungu

500 mg/single dose/1 hour before dental surgery

Intervention Type DRUG

Placebo

500 mg/single dose/1 hour before dental surgery

Intervention Type DRUG

Other Intervention Names

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Mulungu Matusa, Erytrina mulungu

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role collaborator

Liane Maciel de Almeida Souza

OTHER

Sponsor Role lead

Responsible Party

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Liane Maciel de Almeida Souza

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Liane M Souza, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Sergipe

Locations

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Federal University of Sergipe

Aracaju, Sergipe, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 19441926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17268084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17253849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14600397 (View on PubMed)

Other Identifiers

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Mulungu-401-2011

Identifier Type: -

Identifier Source: org_study_id