Laxative Effectiveness of a Phytotherapeutic Tea

NCT ID: NCT00872430

Last Updated: 2009-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2003-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

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).

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Phytotherapeutic tea; laxative tea

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Laboratório Klein Ltda.

UNKNOWN

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Hospital de Clínicas de Porto Alegre

Principal Investigators

Paulo D picon, Coordinator

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

Picon PD, Picon RV, Costa AF, Sander GB, Amaral KM, Aboy AL, Henriques AT. Randomized clinical trial of a phytotherapic compound containing Pimpinella anisum, Foeniculum vulgare, Sambucus nigra, and Cassia augustifolia for chronic constipation. BMC Complement Altern Med. 2010 Apr 30;10:17. doi: 10.1186/1472-6882-10-17.

Reference Type: DERIVED

PMID: 20433751 (View on PubMed)

Other Identifiers

02121

Identifier Type: -

Identifier Source: org_study_id