MedTrace Logo

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

NCT00994851 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2013-03-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SENNA+CASSIA

Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day

DRUG

placebo

Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day

Sponsors & Collaborators

Principal Investigators

  • Jaderson Lima, Study Director · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00994851 on ClinicalTrials.gov