ConstipationPhase 3NCT00990951
Study of Efficacy of Association of Senna Alexandrina Mill and Associations on Functional Intestinal Constipation
A Phase 3 study testing Senna alexandrina and associations in people with Constipation, run by Marjan Industria e Comercio ltda at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Constipation
- What is being tested?
- Senna alexandrina and associations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2010to Jul 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
This is a phase III trial, placebo-controlled with a parallel-group design.
- Conditions
- Constipation
- Being tested
- Senna alexandrina and associations
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senna alexandrina and associationsDrug
Also called Brand name: Tamaril
Drugs: Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub
1 tablet PO twice a day
| Study group | Role | What they receive |
|---|---|---|
| Senna alexandrina and associations | Experimental | Association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub Receives: Drug: Senna alexandrina and associations |
What is being measured
The primary outcome is the main question the study is designed to answer.
average frequency of bowel movements measured at baseline and at 2 weeks of treatment
Measured: 2 weeks
Secondary outcomes (3)
number of consecutive days that patients do not evacuate
Measured: 2 weeks
Proportion of stools with pain and difficulty
Measured: 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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startJun 2010
- Primary completionJul 2014
- Study completionJul 2014 (estimated)
Why it stopped: The study was interrupted by recruitment failure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marjan Industria e Comercio ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria EA Moraes, MD, PhD, Principal investigator, Federal University of Ceara - UNIFAC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990951
- Sponsor's protocol ID
- MJ 3001-09
- Status last verified
- Jul 2014
- First submitted
- 5 Oct 2009
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00990951
- Acronym / sponsor ID
- MJ 3001-09
- Conditions
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study was interrupted by recruitment failure.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Marjan Industria e Comercio ltdaIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase III trial, placebo-controlled with a parallel-group design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Senna alexandrina and associations | Experimental | Drug: Senna alexandrina and associationsAssociation of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senna alexandrina and associationsAlso: Brand name: TamarilDrugs: Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub 1 tablet PO twice a day | Drug | Senna alexandrina and associations |
Primary outcome
average frequency of bowel movements measured at baseline and at 2 weeks of treatment
Time frame: 2 weeks
3 secondary outcomes
number of consecutive days that patients do not evacuate
Time frame: 2 weeks
Proportion of stools with pain and difficulty
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria EA Moraes, MD, PhD principal investigator
Federal University of Ceara - UNIFAC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Senna alexandrina and associations in people with Constipation, run by Marjan Industria e Comercio ltda at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average frequency of bowel movements measured at baseline and at 2 weeks of treatment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.