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

Phase 3

Suspended

• Conditions: Constipation
• Interventions: Drug: Senna alexandrina and associations

• Registration Number: NCT00990951
• Lead Sponsor: Marjan Industria e Comercio ltda

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.

Study Timeline

• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-07
• Study Start: 2010-06
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
average frequency of bowel movements measured at baseline and at 2 weeks of treatment	2 weeks

Secondary Outcome Measures

Name	Time	Method
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
Proportion of stools with pain and difficulty	2 weeks
number of consecutive days that patients do not evacuate	2 weeks

Trial Locations

Locations (1)

Departamento de Fisiologia e Farmacologia; 🇧🇷 Ceará, Fortaleza, Brazil