This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: July 1, 2009
Last updated: October 16, 2012
Last verified: October 2012

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 Intervention Phase
Constipation Drug: SENNA+CASSIA(Naturetti) Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • 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) ]
  • Evaluation of the use of sene extract as rescue medication [ Time Frame: From the baseline to the end of the study (at 30 days) ]

Enrollment: 117
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00931853

Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Study Director: Jaderson Lima Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT00931853     History of Changes
Other Study ID Numbers: SENCA_L_04392
Study First Received: July 1, 2009
Last Updated: October 16, 2012

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Pathological Conditions, Anatomical
Senna Extract
Sennoside A&B
Gastrointestinal Agents processed this record on August 18, 2017