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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
Sanofi-Aventis Administrative Office
São Paulo, Brazil
Measure of the chronic functional constipation symptoms based on the Rome III criteria
Time frame: From the baseline to the end of the study (at 30 days)
Evaluation of the stool aspect based on the Bristol Stool Scale
Time frame: From the baseline to the end of the study (at 30 days)
Evaluation of the use of sene extract as rescue medication
Time frame: From the baseline to the end of the study (at 30 days)
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