Phase 2
N=20
Laxative Effectiveness of a Phytotherapeutic Tea
Chronic Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00872430 ↗Enrolled (actual)
20
Serious AEs
—
Results posted
Mar 2009
Primary outcome: Primary: Intestinal Transit Time — 42.3; 15.66 hours — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Other); Klein Laxative Tea (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Primary completion
- Dec 2002
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intestinal Transit Time |
42.3; 15.66 | <0.001 sig |
| SECONDARY Number of Patients With no Evacuation After Each Intervention Period |
9; 0 | <0.001 sig |
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 randomized crossover placebo-controlled clinical trial in patients with chronic constipation.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00872430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.