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临床试验/NCT01948622
NCT01948622已完成1 期

Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction

Liane Maciel de Almeida Souza1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Changes in anxiety report

研究概览

简要总结

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

详细描述

: 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%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Mulungu

Active Comparator

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

干预措施: Mulungu (Drug)

placebo

Placebo Comparator

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

干预措施: Placebo (Drug)

结局指标

主要结局

Changes in anxiety report

时间窗: Change from baseline to 7 days

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.

次要结局

  • Changes in oxygen saturation(Change from baseline to 2 hours)
  • Changes in blood pressure(Change from baseline to 2 hours)
  • Changes in heart rate(Change from baseline to 2 hours)

研究者

发起方
Liane Maciel de Almeida Souza
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Liane Maciel de Almeida Souza

Assistant Professor

Universidade Federal de Sergipe

研究点 (1)

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