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Laxative Effectiveness of a Phytotherapeutic Tea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872430
First Posted: March 31, 2009
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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 Intervention Phase
Chronic Constipation Other: Placebo Other: Klein Laxative Tea Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Intestinal Transit Time [ Time Frame: day 3 and day 17 ]

Secondary Outcome Measures:
  • Number of Patients With no Evacuation After Each Intervention Period [ Time Frame: day 5 and day 19 ]

Enrollment: 20
Study Start Date: July 2002
Study Completion Date: June 2003
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872430


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):
Responsible Party: Paulo Dornelles Picon, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00872430     History of Changes
Other Study ID Numbers: 02121
First Submitted: November 6, 2008
First Posted: March 31, 2009
Results First Submitted: November 6, 2008
Results First Posted: March 31, 2009
Last Update Posted: July 29, 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
Signs and Symptoms
Laxatives
Cathartics
Gastrointestinal Agents