Laxative Effectiveness of a Phytotherapeutic Tea

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Constipation

Intervention / Treatment
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* Other: Placebo
* Other: Klein Laxative Tea


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo/Laxative tea crossover<br>This arm received placebo in the first period and laxative tea in the second period (after washout period of 9 days). | Other: Placebo<br>* 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.<br>Other: Klein Laxative Tea<br>* 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.<br>* Other names: laxative tea;|
| Active Comparator: Laxative tea/Placebo crossover<br>This arm received laxative tea in the first intervention period and placebo in the second intervention period (after washout period of 9 days). | Other: Placebo<br>* 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.<br>Other: Klein Laxative Tea<br>* 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.<br>* Other names: laxative tea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal Transit Time | Radiologic technique consisting of the ingestion of radiopaque markers, followed by a simple x-ray of the abdomen on day 3 of each intervention period. Standard formula, regarding markers ingested, time of ingestion and markers still present on the colon (counted by radiologist unaware of the treatment allocation), provided transit time. | day 3 and day 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With no Evacuation After Each Intervention Period | The number of patients who had not evacuated on day 5 of each intervention period was obtained using questions 1 and 9 of the Scale for Assessment of Constipation Symptoms based on: 1) How many times have you had a bowel movement in the last 24 hours?; 9) Classification of bowel habit on a scale of 1 (terrible) to 5 (excellent). | day 5 and day 19 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, constipation, phytotherapy