Laxative Effectiveness of a Phytotherapeutic Tea
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Laxative Effectiveness of a Phytotherapeutic Tea: A Randomized Placebo-Controlled Clinical Trial |
- Intestinal Transit Time [ Time Frame: day 3 and day 17 ] [ Designated as safety issue: No ]
- Number of Patients With no Evacuation After Each Intervention Period [ Time Frame: day 5 and day 19 ] [ Designated as safety issue: No ]
| 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:
|
|
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:
|
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| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Brazil | |
| Hospital de Clínicas de Porto Alegre | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90035903 | |
| Principal Investigator: | Paulo D picon, Coordinator | Hospital de Clínicas de Porto Alegre |
More Information
No publications provided by Hospital de Clinicas de Porto Alegre
Additional 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 |
| Study First Received: | November 6, 2008 |
| Results First Received: | November 6, 2008 |
| Last Updated: | June 16, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013