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Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00931853
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : October 17, 2012
Information provided by (Responsible Party):

Brief Summary:

Primary Objective:

  • To evaluate the clinical efficacy of Naturetti (jelly sugar free)
  • To test medication on subjects who suffer chronic functional constipation in 30 days use.

Secondary Objectives:

  • To demonstrate the clinical tolerability when daily used (repeated doses) of the components of the study drug. The components will be evaluated by the adverse events occurrence classified by possibly related, probably related and definitely related
  • To demonstrate the clinical tolerability of the study medication by the continuous use during the second phase study
  • To identify any adverse events related to the study drug
  • To identify any drug interaction.

Condition or disease Intervention/treatment Phase
Constipation Drug: SENNA+CASSIA(Naturetti) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: National Study, Phase III, Parallel, Double Blind, Placebo Comparative and Randomized to Evaluate the Therapeutic Efficacy and Tolerability of the Combination Naturetti® (Cassia Fistula + Senna Alexandrina Miller) in the Chronic Functional Constipation
Study Start Date : September 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SENNA + CASSIA (Naturetti)
Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
Drug: SENNA+CASSIA(Naturetti)
Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days

Primary Outcome Measures :
  1. Measure of the chronic functional constipation symptoms based on the Rome III criteria [ Time Frame: From the baseline to the end of the study (at 30 days) ]

Secondary Outcome Measures :
  1. Evaluation of the stool aspect based on the Bristol Stool Scale [ Time Frame: From the baseline to the end of the study (at 30 days) ]
  2. Evaluation of the use of sene extract as rescue medication [ Time Frame: From the baseline to the end of the study (at 30 days) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • Having chronic functional constipation by ROME IIII criteria
  • Having the majority of the stool as type 1 or 2 by Bristol Stool Scale
  • Female subjects should be using an effective contraceptive method more than 3 months if they are sexually active and on reproductive stage
  • ICF signature
  • Be able to understand and agree to undertake the study procedures
  • Having no contraindication related to the study drug
  • To perform all study visits.

Exclusion criteria:

  • Having previous history or current neurological disorder and/or metabolic one
  • Having constipation caused by previous surgery
  • Having intestinal obstruction including colon/rectum cancer
  • Having endocrine disorder as diabetes mellitus
  • Having Irritable bowel syndrome or inflammatory bowel disease
  • Having multiple sclerosis
  • Having Parkinsons disease
  • Having Hirschsprungs disease and dyssynergy defecation
  • Continuous treatment with the following: analgesics, anticholinergic (antihistamines, antispasmodics, antidepressants, antipsychotics) iron supplements or aluminum, opiates, antihypertensive, calcium channel blockers and ganglionic blocker
  • Treatment with any other laxative medication other than the rescue medication during the study
  • Patients who could not confirm the chronic functional constipation during the phase I study
  • Pregnancy or breast feeding woman
  • Abnormal laboratory results, or clinical result that shows significant by the Investigator
  • Corporeal mass index > 30
  • Patients who have participate in other clinical study within 30 days
  • Unable to fulfill the questionnaire (diary)
  • Any condition that makes impossible to the patient in participates by Investigator opinion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00931853

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Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
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Study Director: Jaderson Lima Sanofi
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Responsible Party: Sanofi Identifier: NCT00931853    
Other Study ID Numbers: SENCA_L_04392
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: October 17, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms
Pathological Conditions, Anatomical