NCT00944268

Brief 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. Patients will be included in sufficient quantity to achieve the minimum number of 124 evaluable patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P25-P50 for phase_3 anxiety

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_3 anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 24, 2009

Status Verified

July 1, 2009

Enrollment Period

3 months

First QC Date

July 22, 2009

Last Update Submit

July 23, 2009

Conditions

AnxietyEfficacyTolerability

Keywords

Passiflora, Crataegus and SalixMild and Moderate anxietyTabletTo evaluate the efficacy and tolerability of the combination

Outcome Measures

Primary Outcomes (1)

  • Hamilton Scales

    30 days

Secondary Outcomes (1)

  • Safety evaluation by adverse events relate.

    30 days

Study Arms (1)

Liquid and solid

EXPERIMENTAL
Drug: Passiflora, Crataegus e Salix

Interventions

Passiflora, Crataegus e SalixDRUG

Comparison of different pharmaceutics forms of drug

Liquid and solid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060650, Brazil

Location

MeSH Terms

Conditions

Anxiety DisordersLymphoma, Follicular

Condition Hierarchy (Ancestors)

Mental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Elie Fiss

    Faculdade de Medicina do ABC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dagoberto Brandão

CONTACT

55 11 36733763dagoberto@phcbrasil.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 23, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

July 24, 2009

Record last verified: 2009-07

Locations

BR(1)