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

NCT ID: NCT00990951

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-07-31

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.

Detailed Description

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

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Senna alexandrina and associations

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

Group Type: EXPERIMENTAL

Senna alexandrina and associations

Intervention Type: DRUG

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

1 tablet PO twice a day

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Brand name: Tamaril

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marjan Industria e Comercio ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria EA Moraes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Ceara - UNIFAC

Locations

Departamento de Fisiologia e Farmacologia

Ceará, Fortaleza, Brazil

Countries

Brazil

Other Identifiers

MJ 3001-09

Identifier Type: -

Identifier Source: org_study_id