drugset / Trial / NCT02129816

Bryophyllum Pinnatum Versus Solifenacin Versus Placebo for Overactive Bladder

NCT02129816 ↗

RandomizedCrossoverQuadruple-blindTreatment

Summary

Overactive bladder (OAB) is an enigmatic condition that is treated symptomatically with anticholinergic drugs (gold standard 2013). In a clinical pilot study was found to be a trend for a higher reduction of the micturition frequency in the Bryophyllum pinnatum group - treated with chewing tablets containing 50% of dried BP leaf press juice - than in the placebo group (n=20, p=0.064) Hypothesis: To test the superior effectivity of Bryophyllum versus Placebo in the treatment of OAB with the needed number (Purpose 1) and to assess in an experimental arm the side effects of BP in comparison to the standard drug (Vesicare) in a clincial trial (Purpose 2).

Timeline

Start
2014-05
Primary completion
2016-04-20
Completion
2017-07-09

Outcome

Missed primary endpoint

paper 9.5±2.2 before and 7.8±1.2 after BP versus 9.3±1.8 before and 9.1±1.6 after placebo, p=0.064. PMID 23218404 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bryophyllum pinnatum Traditional medicine (herbal / TCM) 350 mg —

Indications