Laxative Effectiveness of a Phytotherapeutic Tea

Chronic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872430
• Other study ID #: 02121
• Status: Completed
• Phase: Phase 2
• First received: November 6, 2008
• Last updated: June 16, 2009
• Start date: July 2002
• Est. completion date: June 2003

Study information

• Verified date: June 2009
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2003
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (4)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Rio Grande do Sul, Laboratório Klein Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal Transit Time		day 3 and day 17	No
Secondary	Number of Patients With no Evacuation After Each Intervention Period		day 5 and day 19	No