NCT01948622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
Last Updated

September 23, 2013

Status Verified

September 1, 2013

Enrollment Period

5 months

First QC Date

September 10, 2013

Last Update Submit

September 18, 2013

Conditions

Dental AnxietyImpacted Third Molar Tooth

Keywords

AnxietyThird molar surgeryBlood pressureHeart rateOxygen saturation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in blood pressure

    Change from baseline to 2 hours

  • Changes in heart rate

    Change from baseline to 2 hours

  • Changes in oxygen saturation

    Change from baseline to 2 hours

Study Arms (2)

Mulungu

ACTIVE COMPARATOR

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

Drug: Mulungu

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MulunguDRUG

500 mg/single dose/1 hour before dental surgery

Also known as: Mulungu Matusa, Erytrina mulungu
Mulungu
PlaceboDRUG

500 mg/single dose/1 hour before dental surgery

placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • indication of bilateral extraction of asymptomatic, impacted mandibular third molars

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sergipe

Aracaju, Sergipe, 49060-100, Brazil

Location

Related 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.

    PMID: 19441926BACKGROUND

  • 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.

    PMID: 17268084BACKGROUND

  • 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.

    PMID: 17253849BACKGROUND

  • 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.

    PMID: 14600397BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Liane M Souza, PhD

    Federal University of Sergipe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 23, 2013

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

November 1, 2012

Last Updated

September 23, 2013

Record last verified: 2013-09

Locations

BR(1)