At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 20 enrolled

Drug / intervention

Placebo +1 moreother

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00872430

NCT00872430Phase 2Completed

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

Hospital de Clinicas de Porto Alegre·interventional·Posted Mar 31, 2009·Updated Jun 17, 2009

In Brief

A Phase 2 clinical trial evaluating Placebo and Klein Laxative Tea for Chronic Constipation. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsChronic Constipation

CountriesBrazil

CollaboratorsFederal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Laboratório Klein Ltda.

Timeline

Phase 2CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2002

Primary CompletionDec 2002

Study CompletionJun 2003

First PostedMar 2009

TodayJul 2026

First PostedMar 31, 2009

Enrollment StartJul 1, 2002

Primary CompletionDec 1, 2002

Study CompletionJun 1, 2003

TodayJul 2, 2026

Enrollment to primary: 5 monthsPosted 17.3 years ago

Interventions

Placeboother

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.

Klein Laxative Teaother

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.