Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).
NCT ID: NCT00931853
Last Updated: 2012-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
117 participants
INTERVENTIONAL
2010-09-30
2011-12-31
Brief Summary
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* 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
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SENNA + CASSIA (Naturetti)
Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
SENNA+CASSIA(Naturetti)
Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
Interventions
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SENNA+CASSIA(Naturetti)
Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
Eligibility Criteria
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Inclusion Criteria
* Having the majority of the stool as type 1 or 2 by Bristol Stool Scale
* Female subjects should be using an effective contraceptive method more than 3 months if they are sexually active and on reproductive stage
* ICF signature
* Be able to understand and agree to undertake the study procedures
* Having no contraindication related to the study drug
* To perform all study visits.
Exclusion Criteria
* Having constipation caused by previous surgery
* Having intestinal obstruction including colon/rectum cancer
* Having endocrine disorder as diabetes mellitus
* Having Irritable bowel syndrome or inflammatory bowel disease
* Having multiple sclerosis
* Having Parkinsons disease
* Having Hirschsprungs disease and dyssynergy defecation
* Continuous treatment with the following: analgesics, anticholinergic (antihistamines, antispasmodics, antidepressants, antipsychotics) iron supplements or aluminum, opiates, antihypertensive, calcium channel blockers and ganglionic blocker
* Treatment with any other laxative medication other than the rescue medication during the study
* Patients who could not confirm the chronic functional constipation during the phase I study
* Pregnancy or breast feeding woman
* Abnormal laboratory results, or clinical result that shows significant by the Investigator
* Corporeal mass index \> 30
* Patients who have participate in other clinical study within 30 days
* Unable to fulfill the questionnaire (diary)
* Any condition that makes impossible to the patient in participates by Investigator opinion.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
59 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Jaderson Lima
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
São Paulo, , Brazil
Countries
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Other Identifiers
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SENCA_L_04392
Identifier Type: -
Identifier Source: org_study_id