Laxative Effectiveness of a Phytotherapeutic Tea

• ClinicalTrials.gov Identifier: NCT00872430
• Recruitment Status: Completed
• First Posted: March 31, 2009
• Results First Posted: March 31, 2009
• Last Update Posted: June 17, 2009
• 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.
• Information provided by: Hospital de Clinicas de Porto Alegre

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Constipation	Other: Placebo; Other: Klein Laxative Tea	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Laxative Effectiveness of a Phytotherapeutic Tea: A Randomized Placebo-Controlled Clinical Trial
• Study Start Date: July 2002
• Actual Primary Completion Date: December 2002
• Actual Study Completion Date: June 2003

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Intestinal Transit Time [ Time Frame: day 3 and day 17 ]
   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.

Secondary Outcome Measures :

1. Number of Patients With no Evacuation After Each Intervention Period [ Time Frame: day 5 and day 19 ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil, 90035903

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

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 Clínicas de Porto Alegre

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Paulo Dornelles Picon, Hospital de Clínicas de Porto Alegre
• ClinicalTrials.gov Identifier: NCT00872430
• Other Study ID Numbers: 02121
• First Posted: March 31, 2009
• Results First Posted: March 31, 2009
• Last Update Posted: June 17, 2009
• Last Verified: June 2009

Keywords provided by Hospital de Clinicas de Porto Alegre:

constipation; RCT; phytotherapy

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive; Laxatives; Cathartics; Gastrointestinal Agents