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

Sponsor
Marjan Industria e Comercio ltda (Industry)
Overall Status
Suspended
CT.gov ID
NCT00990951
Collaborator
(none)
80
Enrollment
1
Location
1
Arm
49
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Senna alexandrina and associations
 Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Jul 1, 2014
Anticipated Study Completion Date :
Jul 1, 2014

Arms and Interventions

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

Drug: Senna alexandrina and associations
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. average frequency of bowel movements measured at baseline and at 2 weeks of treatment [2 weeks]

    Secondary Outcome Measures

    1. number of consecutive days that patients do not evacuate [2 weeks]

    2. Proportion of stools with pain and difficulty [2 weeks]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Departamento de Fisiologia e Farmacologia Ceará Fortaleza Brazil

    Sponsors and Collaborators

    • Marjan Industria e Comercio ltda

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marjan Industria e Comercio ltda
    ClinicalTrials.gov Identifier:
    NCT00990951
    Other Study ID Numbers:
    • MJ 3001-09
    First Posted:
    Oct 7, 2009
    Last Update Posted:
    Jul 8, 2014
    Last Verified:
    Jul 1, 2014
    Additional relevant MeSH terms:
    Constipation

    Study Results

    No Results Posted as of Jul 8, 2014