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Primary Objective:
To evaluate the clinical efficacy of Naturetti (capsules) , considering the following criteria:
Secondary Objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SENNA+ CASSIA | Experimental | Daily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days |
|
| Placebo | Placebo Comparator | Daily administration (capsule) of placebo at bedtime, during 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENNA+CASSIA | Drug | Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the evacuation frequency during the treatment and follow-up period | 30 and 45 days | |
| Evaluation of the stools consistency during the treatment and follow-up period | 30 and 45 days | |
| Global evaluation, regarding increase in frequency of evacuation and shape of stools | 30 and 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days without evacuation | 30 days | |
| Proportion of evacuation with pain | 30 days | |
| Proportion of evacuation with strain |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Jaderson Lima, Study Director | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | São Paulo | 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 |
| ID | Term |
|---|---|
| D012676 | Senna Extract |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
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| placebo | Drug | Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day |
|
| 30 days |
| Proportion of evacuation with incomplete sensation | 30 days |
| Proportion of blocked stools | 30 days |
| Proportion of manual maneuvers to facilitate defecation | 30 days |
| Proportion of subjects that adhere to the diet recommended | 30 days |
| Proportion of the patients who have to use rescue medication | 30 days |
| Level of constipation improvement, according to the patient evaluation | 30 days |
| 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 |