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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Constipation

Intervention / Treatment
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* Drug: SENNA+CASSIA
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Chronic functional constipation present, diagnosed by Rome III criteria. Present in most evacuations intestinal feces classified as Type 1 or 2 by the classification of Bristol. Women sexually active and reproductive age, using more than three months effective contraceptive method. Concordance, level of education and consciousness enough to cooperate with the completion of all study procedures. No contraindication to the use of medication in the study. Availability to attend all the visits of the study evaluation. Exclusion criteria: History or presence of neurological disorders and / or metabolism. Persons with constipation caused by previous surgery. Presence of obstructive lesions in the gastrointestinal tract, including colorectal cancer. Irritable bowel syndrome or inflammatory bowel disease. Multiple Sclerosis Parkinson's disease Other abnormalities such as Hirschsprung's disease and Defecation Dissinrgica. Heart disease and / or hypertension. Continuous use of medication such as analgesics, anti-cholinergic (anti-histamines, antispasmodics, antidepressants, anti-psychotics), supplements with iron or aluminum, Opiates, Anti-hypertensive, CALCIUM CHANNEL BLOCKERS Preganglionic and blockers. Use of any other except the laxative rescue medication during the study. Subjects who do not confirm the diagnosis of ICFC during Phase I of the study. Pregnant or breast-feeding period. Laboratory tests outside the normal range, or the result is assessed as clinically significant by the Investigator. Body Mass Index (BMI) over 30. Participation in another clinical study within 30 days. Do not fill the correct Diary Any condition that in view of the researcher impossible the Subject to participate in the study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SENNA+ CASSIA<br>Daily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days | Drug: SENNA+CASSIA<br>* Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day<br>|
| Placebo Comparator: Placebo<br>Daily administration (capsule) of placebo at bedtime, during 30 days | Drug: placebo<br>* Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the evacuation frequency during the treatment and follow-up period |  | 30 and 45 days | 
| Evaluation of the stools consistency during the treatment and follow-up period |  | 30 and 45 days | 
| Global evaluation, regarding increase in frequency of evacuation and shape of stools |  | 30 and 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days without evacuation |  | 30 days | 
| Proportion of evacuation with pain |  | 30 days | 
| Proportion of evacuation with strain |  | 30 days | 
| Proportion of evacuation with incomplete sensation |  | 30 days | 
| Proportion of blocked stools |  | 30 days | 
| Proportion of manual maneuvers to facilitate defecation |  | 30 days | 
| Proportion of subjects that adhere to the diet recommended |  | 30 days | 
| Proportion of the patients who have to use rescue medication |  | 30 days | 
| Level of constipation improvement, according to the patient evaluation |  | 30 days |