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

Primary Purpose

Constipation

Status

Suspended

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Senna alexandrina and associations

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Departamento de Fisiologia e Farmacologia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Senna alexandrina and associations

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

number of consecutive days that patients do not evacuate

Proportion of stools with pain and difficulty

degree of improvement of constipation according to the subjective evaluation of the volunteer, measured by the scores of the Global Assessment of the patient

Full Information

NCT ID

NCT00990951

First Posted

October 5, 2009

Last Updated

July 7, 2014

Sponsor

Marjan Industria e Comercio ltda

1. Study Identification

Unique Protocol Identification Number

NCT00990951

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Suspended

Why Stopped

The study was interrupted by recruitment failure.

Study Start Date

June 2010 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Marjan Industria e Comercio ltda

4. Oversight

Data Monitoring Committee

Yes

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Senna alexandrina and associations

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Senna alexandrina and associations

Other Intervention Name(s)

Brand name: Tamaril

Intervention Description

Drugs: Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub 1 tablet PO twice a day

Primary Outcome Measure Information:

Title

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

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

number of consecutive days that patients do not evacuate

Time Frame

2 weeks

Title

Proportion of stools with pain and difficulty

Time Frame

2 weeks

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria EA Moraes, MD, PhD

Organizational Affiliation

Federal University of Ceara - UNIFAC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Departamento de Fisiologia e Farmacologia

City

Ceará

State/Province

Fortaleza

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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