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Anxiety Control by Erythrina Mulungu

L

Liane Maciel de Almeida Souza

Status and phase

Completed
Phase 2
Phase 1

Conditions

Impacted Third Molar Tooth
Dental Anxiety

Treatments

Drug: Placebo
Drug: Mulungu

Study type

Interventional

Funder types

Other

Identifiers

NCT01948622
Mulungu-401-2011

Details and patient eligibility

About

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

Full 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%.

Enrollment

30 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups, including a placebo group

Mulungu
Active Comparator group
Description:
500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.
Treatment:
Drug: Mulungu
placebo
Placebo Comparator group
Description:
500 mg of starch (2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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