Laxative Effectiveness of a Phytotherapeutic Tea

Hospital de Clinicas de Porto Alegre

Status and phase: Completed; Phase 2

Conditions: Chronic Constipation

Treatments: Other: Placebo; Other: Klein Laxative Tea

Study type: Interventional

Funder types: Other

Identifiers

NCT00872430

02121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Placebo/Laxative tea crossover

Active Comparator group

Description:

This arm received placebo in the first period and laxative tea in the second period (after washout period of 9 days).

Treatment:

Other: Placebo

Other: Klein Laxative Tea

Laxative tea/Placebo crossover

Active Comparator group

Description:

This arm received laxative tea in the first intervention period and placebo in the second intervention period (after washout period of 9 days).

Treatment:

Other: Placebo

Other: Klein Laxative Tea