Constipation Clinical Trial
Official title:
National Study, Phase III, Parallel, Double Blind, Placebo Comparative and Randomized to Evaluate the Therapeutic Efficacy and Tolerability of the Combination Naturetti® (Cassia Fistula + Senna Alexandrina Miller) in the Chronic Functional Constipation.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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