NCT00990951

Brief Summary

The purpose of this study is to evaluate the efficacy of association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub. in patients with functional constipation.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
suspended

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

October 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

4.1 years

First QC Date

October 5, 2009

Last Update Submit

July 7, 2014

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

  • average frequency of bowel movements measured at baseline and at 2 weeks of treatment

    2 weeks

Secondary Outcomes (3)

  • number of consecutive days that patients do not evacuate

    2 weeks

  • Proportion of stools with pain and difficulty

    2 weeks

  • degree of improvement of constipation according to the subjective evaluation of the volunteer, measured by the scores of the Global Assessment of the patient

    2 weeks

Study Arms (1)

Senna alexandrina and associations

EXPERIMENTAL

Association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub

Drug: Senna alexandrina and associations

Interventions

Senna alexandrina and associationsDRUG

Drugs: Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub 1 tablet PO twice a day

Also known as: Brand name: Tamaril
Senna alexandrina and associations

Eligibility Criteria

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

You may qualify if:

  • Patients between 18-65 years with functional constipation by ROME IIII criteria
  • In the opinion of the investigator the patient will adhere to the protocol
  • Voluntary able to understand the nature and purpose of the study, including the risks and adverse effects and with intent to cooperate with the researcher and act in accordance with the requirements of the entire protocol, which was confirmed by signing the Consent Informed

You may not qualify if:

  • hypersensitivity to any component
  • pregnant or lactating
  • abdominal pain of unknown etiology
  • suspected intestinal occlusion and sub-occlusion
  • suspected abdominal inflammatory conditions (as appendicitis, peritonitis, cystitis, endometritis)
  • Crohn disease and colitis
  • Suspected intestinal constipation due abdominal surgery, neurological disorders (as aganglionoses, Parkinson disease, medullar tumor, stroke, multiple sclerosis), systemic sclerosis, multiple myeloma, scleroderma
  • Subjects with congenital mega colon, anorectal congenital malformation, inflammatory bowel disease or intestinal carcinoma
  • history of mal-absorption diseases
  • history of anemia, weight loss or anal bleeding
  • history of hypothyroidism, hyperthyroidism and insulin-dependent diabetes mellitus
  • known of positive result for human immunodeficiency virus test
  • heart, liver, lung or kidney important condition
  • drug or alcohol dependence
  • knowledge or suspicion of malignancy
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Fisiologia e Farmacologia

Ceará, Fortaleza, Brazil

Location

MeSH Terms

Conditions

Constipation

Interventions

SennosidesAssociation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Senna ExtractAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic CompoundsGlycosidesCarbohydratesPlant ExtractsPlant PreparationsBiological ProductsComplex MixturesPsychotherapeutic ProcessesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Maria EA Moraes, MD, PhD

    Federal University of Ceara - UNIFAC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 7, 2009

Study Start

June 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

BR(1)