NCT00872430

Laxative Effectiveness of a Phytotherapeutic Tea

Laxative Effectiveness of a Phytotherapeutic Tea: A Randomized Placebo-Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

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 (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.

Conditions

• Chronic Constipation

Interventions

Type	Name	Description
OTHER	Placebo	In order to produce similar taste and color, 7 drops of caramel color and 10 drops of orange essence were mixed into 1.6 liters of boiling water. The patients received 150 ml of placebo 3 times a day for 5 days.
OTHER	Klein Laxative Tea	The laxative tea was prepared using 1 gram of grinded plant into 150 ml of water, left under infusion by 5 minutes. Patients received 150 ml of tea 3 times a day for 5 days.

Timeline

• Start date: 2002-07-01
• Primary completion: 2002-12-01
• Completion: 2003-06-01
• First posted: 2009-03-31
• Last updated: 2009-06-17
• Results posted: 2009-03-31

Locations

1 site across 1 country: Brazil