Clinical trial NCT00872430: Laxative Effectiveness of a Phytotherapeutic Tea
Official title: Laxative Effectiveness of a Phytotherapeutic Tea: A Randomized Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Constipation
Keywords: constipation
RCT
phytotherapy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Laboratório Klein Ltda.
First posted: 2009-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Intestinal Transit Time
timeFrame: day 3 and day 17
Secondary outcomes:
measure: Number of Patients With no Evacuation After Each Intervention Period
timeFrame: day 5 and day 19
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Paulo D picon, Coordinator
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.