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

This study is currently recruiting participants.
Verified May 2012 by Marjan Industria e Comercio ltda
Sponsor:
Information provided by (Responsible Party):
Marjan Industria e Comercio ltda
ClinicalTrials.gov Identifier:
NCT00990951
First received: October 5, 2009
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Constipation
 Drug: Senna alexandrina and associations
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Marjan Industria e Comercio ltda:

Primary Outcome Measures:
  • average frequency of bowel movements measured at baseline and at 2 weeks of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of consecutive days that patients do not evacuate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Proportion of stools with pain and difficulty [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Brand name: Tamaril

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990951

Contacts
Contact: Jonaina C Oliveira, MD 55-85-32232600 jonaina.qu@ig.com.br
Contact: Maria EA Moraes, MD, PhD 55-85-3223-8903 pesquisa@unifac.med.br

Locations
Brazil
Departamento de Fisiologia e Farmacologia Recruiting
Ceará, Fortaleza, Brazil
Contact: Jonaina C Oliveira, MD     55-85-32232600     jonaina.qu@ig.com.br    
Contact: Maria EA Moraes, MD     55-85-3223-8903     pesquisa@unifac.med.br    
Principal Investigator: Maria EA Moraes, MD, PhD            
Sponsors and Collaborators
Marjan Industria e Comercio ltda
Investigators
Principal Investigator: Maria EA Moraes, MD, PhD Federal University of Ceara - UNIFAC
  More Information

No publications provided

Responsible Party: Marjan Industria e Comercio ltda
ClinicalTrials.gov Identifier: NCT00990951     History of Changes
Other Study ID Numbers: MJ 3001-09
Study First Received: October 5, 2009
Last Updated: May 23, 2012
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Senna Extract
Sennoside A&B
 Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013