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Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.

2014-08-27 03:18:40 | BioPortfolio

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.

Study Design

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

Conditions

Constipation

Intervention

SENNA+CASSIA, placebo

Location

Sanofi-Aventis Administrative Office
Sao Paulo
Brazil

Status

Suspended

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:40-0400

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Medical and Biotech [MESH] Definitions

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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.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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