Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).
Phase 3
Completed
- Conditions
- Constipation
- Interventions
- Drug: SENNA+CASSIA(Naturetti)
- Registration Number
- NCT00931853
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SENNA + CASSIA (Naturetti) SENNA+CASSIA(Naturetti) Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
- Primary Outcome Measures
Name Time Method Measure of the chronic functional constipation symptoms based on the Rome III criteria From the baseline to the end of the study (at 30 days)
- Secondary Outcome Measures
Name Time Method Evaluation of the stool aspect based on the Bristol Stool Scale From the baseline to the end of the study (at 30 days) Evaluation of the use of sene extract as rescue medication From the baseline to the end of the study (at 30 days)
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇧🇷Sao Paulo, Brazil