Status:
COMPLETED
Laxative Effectiveness of a Phytotherapeutic Tea
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Chronic Constipation
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the efficacy and safety of a phytotherapeutic laxative tea, composed by Pimpinella anisum, Foeniculum vulgare, Sambucus nigra and Cassia angustifolia, in a randomi...
Detailed Description
The Klein Laxative Tea is a pharmaceutical phytotherapeutic product that's been used for several years in Brazil for the treatment of constipation. This product contains fruit of Pimpinella anisum (gr...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- patients with 18 to 55 years old with chronic constipation according to the criteria of the American Association of Gastroenterology (AAG);
- patients should present good understanding and collaboration capacity, an not be in use of other medications with effects on the intestinal habit;
- patients with no abnormalities in the exams;
- willing to sign a written informed consent;
- women in fertile age should make use of appropriate anti-conception.
- Exclusion Criteria:
- pregnant or breast feeding women;
- patients with history of abuse of alcohol or use of drugs;
- significant or not-controlled disease, except constipation.
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00872430
Start Date
July 1 2002
End Date
June 1 2003
Last Update
June 17 2009
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035903