Anxiety Control by Erythrina Mulungu

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الحالةمنجز

الرعاة

Liane Maciel de Almeida Souza

المتعاونون

University of Campinas, Brazil

تجربة سريرية: NCT01948622

BioSeek: NCT01948622

الكلمات الدالة

نبذة مختصرة

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

وصف

: 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%.

تواريخ

آخر التحقق:	08/31/2013
تم الإرسال لأول مرة:	09/09/2013
تم إرسال التسجيل المقدر:	09/17/2013
أول نشر:	09/22/2013
تم إرسال آخر تحديث:	09/17/2013
آخر تحديث تم نشره:	09/22/2013
تاريخ بدء الدراسة الفعلي:	12/31/2011
تاريخ الإنجاز الأساسي المقدر:	05/31/2012
التاريخ المتوقع لانتهاء الدراسة:	10/31/2012

حالة أو مرض

Dental Anxiety

Impacted Third Molar Tooth

التدخل / العلاج

Drug: Mulungu

Drug: placebo

مرحلة

مرحلة 1/مرحلة 2

مجموعات الذراع

ذراع	التدخل / العلاج
Active Comparator: Mulungu 500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.	Drug: Mulungu 500 mg/single dose/1 hour before dental surgery
Placebo Comparator: placebo 500 mg of starch (2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.	Drug: placebo 500 mg/single dose/1 hour before dental surgery

معايير الأهلية

الأعمار المؤهلة للدراسة	18 Years إلى 18 Years
الأجناس المؤهلة للدراسة	All
يقبل المتطوعين الأصحاء	نعم
المعايير	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

النتيجة

مقاييس النتائج الأولية

1. Changes in anxiety report [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.

مقاييس النتائج الثانوية

1. Changes in blood pressure [Change from baseline to 2 hours]

blood pressure (mmHg) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.

2. Changes in heart rate [Change from baseline to 2 hours]

heart rate (bpm) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.

3. Changes in oxygen saturation [Change from baseline to 2 hours]

oxygen saturation (SpO2) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.