- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00990951
Study of Efficacy of Association of Senna Alexandrina Mill and Associations on Functional Intestinal Constipation
July 7, 2014 updated by: Marjan Industria e Comercio ltda
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
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed Description
This is a phase III trial, placebo-controlled with a parallel-group design.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fortaleza
-
Ceará, Fortaleza, Brazil
- Departamento de Fisiologia e Farmacologia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Senna alexandrina and associations
Association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub
|
Drugs: Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub 1 tablet PO twice a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
average frequency of bowel movements measured at baseline and at 2 weeks of treatment
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of consecutive days that patients do not evacuate
Time Frame: 2 weeks
|
2 weeks
|
Proportion of stools with pain and difficulty
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria EA Moraes, MD, PhD, Federal University of Ceara - UNIFAC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
July 1, 2014
Study Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
October 5, 2009
First Submitted That Met QC Criteria
October 5, 2009
First Posted (Estimate)
October 7, 2009
Study Record Updates
Last Update Posted (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 7, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MJ 3001-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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