Dental AnxietyPhase 1/2NCT01948622
Anxiety Control by Erythrina Mulungu
A Phase 1/2 study testing Mulungu in people with Dental Anxiety and Impacted Third Molar Tooth, run by Liane Maciel de Almeida Souza at 1 site in Brazil.
Trial summary
This study evaluated the effectiveness of the Erythrina mulungu in controlling anxiety in patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Impacted Third Molar Tooth
- What is being tested?
- Mulungu
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Nov 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- indication of bilateral extraction of asymptomatic, impacted mandibular third molars
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction
This study evaluated the effectiveness of the Erythrina mulungu in controlling anxiety in patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.
Read the detailed 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%.
- Conditions
- Dental Anxiety, Impacted Third Molar Tooth
- Being tested
- Mulungu, Placebo
- Keywords
- Anxiety, Third molar surgery, Blood pressure, Heart rate, Oxygen saturation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MulunguDrug
Also called Mulungu Matusa, Erytrina mulungu
500 mg/single dose/1 hour before dental surgery
PlaceboDrug
500 mg/single dose/1 hour before dental surgery
| Study group | Role | What they receive |
|---|---|---|
| Mulungu | Active comparator | 500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) administered v.o., one hour before the surgical procedure. Receives: Drug: Mulungu |
| placebo | Placebo comparator | 500 mg of starch (2 capsules of 250 mg) administered v.o., one hour before the surgical procedure. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 7 days
Secondary outcomes (3)
Changes in blood pressure
blood pressure (mmHg) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.
Measured: Change from baseline to 2 hours
Changes in heart rate
heart rate (bpm) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.
Measured: Change from baseline to 2 hours
Changes in oxygen saturation
oxygen saturation (SpO2) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.
Measured: Change from baseline to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liane Maciel de Almeida Souza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil
- Responsible party
- Sponsor-investigator, Liane Maciel de Almeida Souza, Universidade Federal de Sergipe
- Investigators
- Liane M Souza, PhD, Principal investigator, Federal University of Sergipe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948622
- Sponsor's protocol ID
- Mulungu-401-2011
- Status last verified
- Sep 2013
- First submitted
- 10 Sep 2013
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19441926Flausino 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.
PubMed 17268084Flausino 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.
PubMed 17253849Onusic 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.
PubMed 14600397
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction
- ClinicalTrials.gov ID
- NCT01948622
- Acronym / sponsor ID
- Mulungu-401-2011
- Conditions
- Dental Anxiety, Impacted Third Molar Tooth
- Keywords
- Anxiety, Third molar surgery, Blood pressure, Heart rate, Oxygen saturation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Liane Maciel de Almeida SouzaUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
: 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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulungu | Active comparator | Drug: Mulungu500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) administered v.o., one hour before the surgical procedure. |
| placebo | Placebo comparator | Drug: Placebo500 mg of starch (2 capsules of 250 mg) administered v.o., one hour before the surgical procedure. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- indication of bilateral extraction of asymptomatic, impacted mandibular third molars
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MulunguAlso: Mulungu Matusa, Erytrina mulungu500 mg/single dose/1 hour before dental surgery | Drug | Mulungu |
| Placebo500 mg/single dose/1 hour before dental surgery | Drug | placebo |
Primary outcome
Changes in anxiety report
Time frame: 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.
3 secondary outcomes
Changes in blood pressure
Time frame: Change from baseline to 2 hours
Changes in heart rate
Time frame: Change from baseline to 2 hours
Changes in oxygen saturation
Time frame: Change from baseline to 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
- Background: PubMed 19441926Balbani 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.
- Background: PubMed 17268084Flausino 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.
- Background: PubMed 17253849Flausino 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.
- Background: PubMed 14600397Onusic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liane M Souza, PhD principal investigator
Federal University of Sergipe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mulungu in people with Dental Anxiety and Impacted Third Molar Tooth, run by Liane Maciel de Almeida Souza at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in anxiety report (time frame: Change from baseline to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01948622, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2013.