Laxative Effectiveness of a Phytotherapeutic Tea
Клучни зборови
Апстракт
Опис
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.
Датуми
| Последен пат проверено: | 05/31/2009 |
| Прво доставено: | 11/05/2008 |
| Поднесено е проценето запишување: | 03/29/2009 |
| Прво објавено: | 03/30/2009 |
| Последното ажурирање е доставено: | 06/15/2009 |
| Последно ажурирање објавено: | 06/16/2009 |
| Датум на први доставени резултати: | 11/05/2008 |
| Датум на први доставени резултати за КК: | 03/29/2009 |
| Датум на објавување на првите резултати: | 03/30/2009 |
| Крај на датумот на започнување на студијата: | 06/30/2002 |
| Проценет датум на примарно завршување: | 11/30/2002 |
| Проценет датум на завршување на студијата: | 05/31/2003 |
Состојба или болест
Интервенција / третман
Other: Placebo
Other: Klein Laxative Tea
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| 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). |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | 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. |
Исход
Мерки на примарниот исход
1. Intestinal Transit Time [day 3 and day 17]
Секундарни мерки на исходот
1. Number of Patients With no Evacuation After Each Intervention Period [day 5 and day 19]
