Laxative Effectiveness of a Phytotherapeutic Tea

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Constipation
• Intervention / Treatment: Other: Placebo; Other: Klein Laxative Tea

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035903
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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).	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.; Other Names: Phytotherapeutic tea; laxative tea
ACTIVE_COMPARATOR: 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).	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.; Other Names: Phytotherapeutic tea; laxative tea

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Federal University of Rio Grande do Sul; Conselho Nacional de Desenvolvimento Científico e Tecnológico; Laboratório Klein Ltda.
• Investigators: Principal Investigator: Paulo D picon, Coordinator, Hospital de Clinicas de Porto Alegre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (ACTUAL): December 1, 2002
• Study Completion (ACTUAL): June 1, 2003

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: March 30, 2009
• First Posted (ESTIMATE): March 31, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 17, 2009
• Last Update Submitted That Met QC Criteria: June 16, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: phytotherapy; RCT; constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Gastrointestinal Agents; Laxatives; Cathartics
• Other Study ID Numbers: 02121