Clinical trial NCT00990951: Study of Efficacy of Association of Senna Alexandrina Mill and Associations on Functional Intestinal Constipation
Official title: 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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Constipation
Lead sponsor: Marjan Industria e Comercio ltda
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: This is a phase III trial, placebo-controlled with a parallel-group design.

Eligibility criteria: 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

Primary outcomes:
measure: average frequency of bowel movements measured at baseline and at 2 weeks of treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: number of consecutive days that patients do not evacuate
timeFrame: 2 weeks
measure: Proportion of stools with pain and difficulty
timeFrame: 2 weeks
measure: degree of improvement of constipation according to the subjective evaluation of the volunteer, measured by the scores of the Global Assessment of the patient
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Ceará
country: Brazil
facility: Departamento de Fisiologia e Farmacologia
state: Fortaleza
Study officials:
affiliation: Federal University of Ceara - UNIFAC
name: Maria EA Moraes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: