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

Marjan

Status and phase

Suspended

Phase 3

Conditions

Constipation

Treatments

Drug: Senna alexandrina and associations

Study type

Interventional

Funder types

Industry

Identifiers

NCT00990951

MJ 3001-09

Details and patient eligibility

About

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.

Full description

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

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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