AnxietyPhase 3E01ATCAL0308NCT00944268
Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety
A Phase 3 study testing Passiflora, Crataegus e Salix in people with Anxiety and Efficacy, run by Ativus Farmaceutica Ltda at 1 site in Brazil.
Trial summary
To evaluate the efficacy and tolerability of the combination use of Passiflora incarnata L, Crataegus oxyacantha and Salix alba L in mild and moderate anxiety. Clinical study phase III, multicenter, prospective, open. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Efficacy, Tolerability
- What is being tested?
- Passiflora, Crataegus e Salix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to Jan 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who achieve scores between 18 and 29 points in the Hamilton Scale for Anxiety;
- Individuals of any ethnic group male and female, aged above 18 years;
- Consent of the subject of research (a consent form signed).
Who cannot join
- Patients with known hypersensitivity to any components of the formula;
- Pregnant women and nursing mothers;
- Patients with endogenous depression, schizophrenia, suicidal tendency;
- Patients with heart disease unabated, unabated kidney, liver and lung unabated unabated, at the discretion of the investigator;
- Addiction to drugs, including alcohol, at the discretion of the investigator;
- Patients who are using any medication that could interfere with the effect of the drug under study;
- Impossibility of compliance to the protocol
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060650
Elie Fiss, 55 1149935469, eliefiss@uol.com.br
Elie Fiss
About this study
Official title: Clinical Study Phase III, Multicenter, Prospective, Open to Evaluate the Efficacy and Tolerability of the Combination Use of Passiflora Incarnata L, Crataegus Oxyacantha and Salix Alba L in Mild and Moderate Anxiety
To evaluate the efficacy and tolerability of the combination use of Passiflora incarnata L, Crataegus oxyacantha and Salix alba L in mild and moderate anxiety.
Clinical study phase III, multicenter, prospective, open.
Patients will be included in sufficient quantity to achieve the minimum number of 124 evaluable patients.
- Conditions
- Anxiety, Efficacy, Tolerability
- Being tested
- Passiflora, Crataegus e Salix
- Keywords
- Passiflora, Crataegus and Salix, Mild and Moderate anxiety, Tablet, To evaluate the efficacy and tolerability of the combination
- Medical subject headings
- Anxiety Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passiflora, Crataegus e SalixDrug
Comparison of different pharmaceutics forms of drug
| Study group | Role | What they receive |
|---|---|---|
| Liquid and solid | Experimental | Not described Receives: Drug: Passiflora, Crataegus e Salix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Scales
Measured: 30 days
Secondary outcomes (1)
Safety evaluation by adverse events relate.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ativus Farmaceutica Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elie Fiss, Principal investigator, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944268
- Sponsor's protocol ID
- E01-AT-CAL-03-08
- Acronym
- E01ATCAL0308
- Status last verified
- Jul 2009
- First submitted
- 22 Jul 2009
- Last updated
- 24 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Phase III, Multicenter, Prospective, Open to Evaluate the Efficacy and Tolerability of the Combination Use of Passiflora Incarnata L, Crataegus Oxyacantha and Salix Alba L in Mild and Moderate Anxiety
- ClinicalTrials.gov ID
- NCT00944268
- Acronym / sponsor ID
- E01ATCAL0308 / E01-AT-CAL-03-08
- Conditions
- Anxiety, Efficacy, Tolerability
- Keywords
- Passiflora, Crataegus and Salix, Mild and Moderate anxiety, Tablet, To evaluate the efficacy and tolerability of the combination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Ativus Farmaceutica LtdaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 23 Jul 2009 (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.
To evaluate the efficacy and tolerability of the combination use of Passiflora incarnata L, Crataegus oxyacantha and Salix alba L in mild and moderate anxiety.
Clinical study phase III, multicenter, prospective, open.
Patients will be included in sufficient quantity to achieve the minimum number of 124 evaluable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liquid and solid | Experimental | Drug: Passiflora, Crataegus e Salix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who achieve scores between 18 and 29 points in the Hamilton Scale for Anxiety;
- Individuals of any ethnic group male and female, aged above 18 years;
- Consent of the subject of research (a consent form signed).
Key exclusion criteria (7 listed)
- Patients with known hypersensitivity to any components of the formula;
- Pregnant women and nursing mothers;
- Patients with endogenous depression, schizophrenia, suicidal tendency;
- Patients with heart disease unabated, unabated kidney, liver and lung unabated unabated, at the discretion of the investigator;
- Addiction to drugs, including alcohol, at the discretion of the investigator;
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 |
|---|---|---|
| Passiflora, Crataegus e SalixComparison of different pharmaceutics forms of drug | Drug | Liquid and solid |
Primary outcome
Hamilton Scales
Time frame: 30 days
1 secondary outcome
Safety evaluation by adverse events relate.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2009.
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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.
Elie Fiss principal investigator
Faculdade de Medicina do ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Passiflora, Crataegus e Salix in people with Anxiety and Efficacy, run by Ativus Farmaceutica Ltda 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Jul 2009. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dagoberto Brandão (55 11 36733763, dagoberto@phcbrasil.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Scales (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2009.