Study of Efficacy of Association of Senna Alexandrina Mill and Associations on Functional Intestinal Constipation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub. in patients with functional constipation.

Detailed Description
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This is a phase III trial, placebo-controlled with a parallel-group design.

Official Title
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Double-blind, Randomized, Placebo-controlled Study of Efficacy of Association of Senna Alexandrina, Cassia Fistula, Tamarindus Indica, Coriandrum Sativum, Periandra Mediterranea in Patients With Functional Intestinal Constipation

Conditions
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Constipation

Intervention / Treatment
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* Drug: Senna alexandrina and associations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18-65 years with functional constipation by ROME IIII criteria In the opinion of the investigator the patient will adhere to the protocol Voluntary able to understand the nature and purpose of the study, including the risks and adverse effects and with intent to cooperate with the researcher and act in accordance with the requirements of the entire protocol, which was confirmed by signing the Consent Informed Exclusion Criteria: hypersensitivity to any component pregnant or lactating abdominal pain of unknown etiology suspected intestinal occlusion and sub-occlusion suspected abdominal inflammatory conditions (as appendicitis, peritonitis, cystitis, endometritis) Crohn disease and colitis Suspected intestinal constipation due abdominal surgery, neurological disorders (as aganglionoses, Parkinson disease, medullar tumor, stroke, multiple sclerosis), systemic sclerosis, multiple myeloma, scleroderma Subjects with congenital mega colon, anorectal congenital malformation, inflammatory bowel disease or intestinal carcinoma history of mal-absorption diseases history of anemia, weight loss or anal bleeding history of hypothyroidism, hyperthyroidism and insulin-dependent diabetes mellitus known of positive result for human immunodeficiency virus test heart, liver, lung or kidney important condition drug or alcohol dependence knowledge or suspicion of malignancy body mass index < 18 body mass index > 30 participation on any experimental study 12 months prior this study familiar history of colon carcinoma or inflammatory disease Lack of adherence to the procedures of the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 alexandrina and associations<br>Association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub | Drug: Senna alexandrina and associations<br>* Drugs: Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub 1 tablet PO twice a day<br>* Other names: Brand name: Tamaril;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average frequency of bowel movements measured at baseline and at 2 weeks of treatment |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of consecutive days that patients do not evacuate |  | 2 weeks | 
| Proportion of stools with pain and difficulty |  | 2 weeks | 
| degree of improvement of constipation according to the subjective evaluation of the volunteer, measured by the scores of the Global Assessment of the patient |  | 2 weeks |