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

Constipation Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00990951
• Other study ID #: MJ 3001-09
• Status: Suspended
• Phase: Phase 3
• First received: October 5, 2009
• Last updated: July 7, 2014
• Start date: June 2010
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Marjan Industria e Comercio ltda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Senna alexandrina and associations
Drugs: Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub 1 tablet PO twice a day

Locations

Country	Name	City	State
Brazil	Departamento de Fisiologia e Farmacologia	Ceará	Fortaleza

Sponsors (1)

Lead Sponsor	Collaborator
Marjan Industria e Comercio ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average frequency of bowel movements measured at baseline and at 2 weeks of treatment		2 weeks	No
Secondary	number of consecutive days that patients do not evacuate		2 weeks	No
Secondary	Proportion of stools with pain and difficulty		2 weeks	No
Secondary	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	No