Study of Efficacy of Association of Senna Alexandrina Mill and Associations on Functional Intestinal Constipation

July 7, 2014 updated by: Marjan Industria e Comercio ltda

Double-blind, Randomized, Placebo-controlled Study of Efficacy of Association of Senna Alexandrina, Cassia Fistula, Tamarindus Indica, Coriandrum Sativum, Periandra Mediterranea in Patients With Functional Intestinal Constipation

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.

Study Overview

Status

Suspended

Conditions

Detailed Description

This is a phase III trial, placebo-controlled with a parallel-group design.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Fortaleza
      • Ceará, Fortaleza, Brazil
        • Departamento de Fisiologia e Farmacologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • body mass index < 18
  • body mass index > 30
  • participation on any experimental study 12 months prior this study
  • familiar history of colon carcinoma or inflammatory disease
  • Lack of adherence to the procedures of the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Senna alexandrina and associations
Association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub

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

1 tablet PO twice a day

Other Names:
  • Brand name: Tamaril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
average frequency of bowel movements measured at baseline and at 2 weeks of treatment
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
number of consecutive days that patients do not evacuate
Time Frame: 2 weeks
2 weeks
Proportion of stools with pain and difficulty
Time Frame: 2 weeks
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
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maria EA Moraes, MD, PhD, Federal University of Ceara - UNIFAC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (Estimate)

October 7, 2009

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 7, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MJ 3001-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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