Anxiety DisordersPhase 3NCT01178632
Therapeutic Effect of an Herbal Medicine on Anxiety
A Phase 3 study testing Passiflora and Valeriana officinalis in people with Anxiety Disorders, run by Millet Roux at 1 site in Brazil.
Trial summary
Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Passiflora and Valeriana officinalis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Jul 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of generalized anxiety disorder
- HAM-A scale > 17 and <30
Who cannot join
- HAM-A scale > 30
- Psychotherapy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Pharmacology Unit - Unifac
Fortaleza, Ceará, 60430-270
MARIA ELISABETE A MORAES, MD, PhD
ALEXANDRE AQUINO CAMARA, MD
About this study
Official title: A Double-blind, Randomized, Controlled, Phase III Study of an Herbal Medicine Association for Generalized Anxiety Disorder
Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit.
Read the detailed description
The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks.
The improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A).
Does the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?
- Conditions
- Anxiety Disorders
- Being tested
- Passiflora, Valeriana officinalis
- Keywords
- Herbal, Phytotherapy, Passiflora, Valeriana, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PassifloraDrug
Also called PASSIFLORINE
01 tablet Passiflora p.o., b.i.d.
Valeriana officinalisDrug
Also called VALERIANE
Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Passiflora, Anxiety Disorders | Experimental | 1 tablet Passiflora;Crataegus;Salix; PO;BID Receives: Drug: Passiflora |
| Valeriane, Anxiety Disorder | Active comparator | 1 tablet Valeriana officinalis, PO, BID Receives: Drug: Valeriana officinalis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton anxiety scale score
The primary outcome measure for effectiveness will be the score of the Hamilton Anxiety Scale (HAM-A). This scale will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.
Measured: Four weeks
Secondary outcomes (2)
Insomnia gravity index
The secondary outcome measure for effectiveness will be the score of the Insomnia gravity index. This questionnaire will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.
Measured: Four weeks
Clinical global impression rate scale and Patient global evaluation rate scale
The other secondary outcome measure for effectiveness will be the clinical global impression rate scale and patient global evaluation rate scale. These scales will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Millet Roux
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MARIA ELISABETE A MORAES, MD, PhD, Study director, CLINICAL PHARMACOLOGY UNIT - UNIFAC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178632
- Sponsor's protocol ID
- MR4009
- Status last verified
- Aug 2010
- First submitted
- 8 Aug 2010
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Controlled, Phase III Study of an Herbal Medicine Association for Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT01178632
- Acronym / sponsor ID
- MR4009
- Conditions
- Anxiety Disorders
- Keywords
- Herbal, Phytotherapy, Passiflora, Valeriana, Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Millet RouxIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 10 Aug 2010 (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.
Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit.
Detailed description
The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks.
The improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A).
Does the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passiflora, Anxiety Disorders | Experimental | Drug: Passiflora1 tablet Passiflora;Crataegus;Salix; PO;BID |
| Valeriane, Anxiety Disorder | Active comparator | Drug: Valeriana officinalis1 tablet Valeriana officinalis, PO, BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of generalized anxiety disorder
- HAM-A scale > 17 and <30
Key exclusion criteria (2 listed)
- HAM-A scale > 30
- Psychotherapy
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 |
|---|---|---|
| PassifloraAlso: PASSIFLORINE01 tablet Passiflora p.o., b.i.d. | Drug | Passiflora, Anxiety Disorders |
| Valeriana officinalisAlso: VALERIANEActive Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d. | Drug | Valeriane, Anxiety Disorder |
Primary outcome
Hamilton anxiety scale score
Time frame: Four weeks
The primary outcome measure for effectiveness will be the score of the Hamilton Anxiety Scale (HAM-A). This scale will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.
2 secondary outcomes
Insomnia gravity index
Time frame: Four weeks
Clinical global impression rate scale and Patient global evaluation rate scale
Time frame: Four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
- ANXIETY DISORDERSLink provided by the sponsor.
- Passion FlowerLink provided by the sponsor.
- Valeriana officinalisLink provided by the sponsor.
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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.
MARIA ELISABETE A MORAES, MD, PhD study director
CLINICAL PHARMACOLOGY UNIT - UNIFAC
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 and Valeriana officinalis in people with Anxiety Disorders, run by Millet Roux 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 2 inclusion and 2 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 10 Aug 2010. 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 MARIA ELISABETE A MORAES, MD, PhD (5585-32232903, betemora@matrix.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton anxiety scale score (time frame: Four weeks). 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 10 Aug 2010.