Laxative Effectiveness of a Phytotherapeutic Tea
Schlüsselwörter
Abstrakt
Beschreibung
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 (green anises), fruit of Foeniculum vulgare (fennel), flowers of Sambucus nigra (elder tree) and flowers of Cassia angustifolia (senna). In spite of the beneficial effects of its components, separately demonstrated in vitro, it never had its effectiveness appraised in a randomized clinical trial.The purpose of this study was to evaluate the efficacy and safety of this product in a randomized crossover placebo-controlled clinical trial. Twenty patients presenting with the criteria of the American Association of Gastroenterology for chronic constipation were included, and concluded a two-phase crossover study. The primary endpoint was the evaluation of the intestinal transit time measured through radiological technique. The secondary endpoints were the number of evacuations, subjective impression of the quality in the intestinal habit, quality of life appraised through WHOQOL-brief and adverse effects.
Termine
| Zuletzt überprüft: | 05/31/2009 |
| Zuerst eingereicht: | 11/05/2008 |
| Geschätzte Einschreibung eingereicht: | 03/29/2009 |
| Zuerst veröffentlicht: | 03/30/2009 |
| Letztes eingereichtes Update: | 06/15/2009 |
| Letztes Update veröffentlicht: | 06/16/2009 |
| Datum der ersten eingereichten Ergebnisse: | 11/05/2008 |
| Datum der ersten eingereichten QC-Ergebnisse: | 03/29/2009 |
| Datum der ersten veröffentlichten Ergebnisse: | 03/30/2009 |
| Tatsächliches Startdatum der Studie: | 06/30/2002 |
| Geschätztes primäres Abschlussdatum: | 11/30/2002 |
| Voraussichtliches Abschlussdatum der Studie: | 05/31/2003 |
Zustand oder Krankheit
Intervention / Behandlung
Other: Placebo
Other: Klein Laxative Tea
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Active Comparator: Placebo/Laxative tea crossover This arm received placebo in the first period and laxative tea in the second period (after washout period of 9 days). | |
| Active Comparator: Laxative tea/Placebo crossover This arm received laxative tea in the first intervention period and placebo in the second intervention period (after washout period of 9 days). |
Zulassungskriterien
| Altersberechtigt für das Studium | 18 Years Zu 18 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | 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. |
Ergebnis
Primäre Ergebnismaße
1. Intestinal Transit Time [day 3 and day 17]
Sekundäre Ergebnismaße
1. Number of Patients With no Evacuation After Each Intervention Period [day 5 and day 19]
