Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
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.
Secondary Objective:
- 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.