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To evaluate the clinical efficacy of Naturetti (capsules) , considering the following criteria:
- Evacuation frequency during the treatment and follow-up period
- Consistency of stools during the treatment and follow-up period
- Global evaluation, regarding increase in frequency of evacuation and shape of stools.
- Number of days without evacuation
- Proportion of evacuation with pain
- Proportion of evacuation with strain
- Proportion of evacuation with incomplete sensation
- Proportion of blocked stools
- Proportion of manual maneuvers to facilitate defecation
- Proportion of subjects that adhere to the diet recommended
- Proportion of the patients who have to use rescue medication
- Level of constipation improvement, according to the patient evaluation
- To evaluate clinical tolerability of the study medication by the continuous use
- To evaluate the occurrence of adverse events related to the study drug
- To identify any drug interaction.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Sanofi-Aventis Administrative Office
Published on BioPortfolio: 2014-08-27T03:18:40-0400
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A plant genus of the family FABACEAE. SENNA EXTRACT is obtained from members of this genus. Members contain ANTHRAQUINONES and have been an ingredient in laxatives (CATHARTICS). Many species of the CASSIA genus have been reclassified into this genus. This bush should not be confused with the Cassia tree (CINNAMOMUM).
A plant genus of the family FABACEAE. Many species of this genus, including the medicinal C. senna and C. angustifolia, have been reclassified into the Senna genus (SENNA PLANT) and some to CHAMAECRISTA.
A plant genus of the family FABACEAE. Some species were reclassified from CASSIA and Senna.
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