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The study was interrupted by recruitment failure.
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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.
This is a phase III trial, placebo-controlled with a parallel-group design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Senna alexandrina and associations | Experimental | Association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senna alexandrina and associations | Drug | Drugs: Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub 1 tablet PO twice a day |
| Measure | Description | Time Frame |
|---|---|---|
| average frequency of bowel movements measured at baseline and at 2 weeks of treatment | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| number of consecutive days that patients do not evacuate | 2 weeks | |
| Proportion of stools with pain and difficulty | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria EA Moraes, MD, PhD | Federal University of Ceara - UNIFAC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departamento de Fisiologia e Farmacologia | Ceará | Fortaleza | Brazil |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000081226 | Sennosides |
| D001244 | Association |
| ID | Term |
|---|---|
| D012676 | Senna Extract |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
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|
| 2 weeks |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D013811 | Psychotherapeutic Processes |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |