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Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).

NCT00931853 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2012-10-17

No results posted yet for this study

Summary

Primary Objective:

* To evaluate the clinical efficacy of Naturetti (jelly sugar free)
* To test medication on subjects who suffer chronic functional constipation in 30 days use.

Secondary Objectives:

* To demonstrate the clinical tolerability when daily used (repeated doses) of the components of the study drug. The components will be evaluated by the adverse events occurrence classified by possibly related, probably related and definitely related
* To demonstrate the clinical tolerability of the study medication by the continuous use during the second phase study
* To identify any adverse events related to the study drug
* To identify any drug interaction.

Conditions

Interventions

DRUG

SENNA+CASSIA(Naturetti)

Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days

Sponsors & Collaborators

Principal Investigators

  • Jaderson Lima · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Brazil

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00931853 on ClinicalTrials.gov