Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk

Clinical Trial to Study the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00507715

Enrollment

Registered

2007-07-26

Start date

2006-09-30

Completion date

2006-11-30

Last updated

2007-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease, Idiopathic

Keywords

Parkinson's Disease, Idiopathic, l-dopa levels, plantago ovata husk

Brief summary

The purpose of this trial is to study the effect of the association levodopa/carbidopa with plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being treated with levodopa/carbidopa.

Detailed description

Although the treatment with l-dopa is the election treatment for Parkinson´s disease, a high number of patients develop motor complications, including, fluctuations and dyscinesia after some years of treatment. The origin of the fluctuations is not well established, but it could be attributed, al least partially, a pharmacokinetics factors. So that, it could improve the answer and reduce the adverse reaction if we reach more stable levels of L-dopa in the circulation. The first experimental studies in animals showed that Plantago ovata husk has an influence in the pharmacokinetics parameters of L-dopa, obtaining more stable levels.

Interventions

DRUGPlantago ovata husk

5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days

OTHERhemicellulose crystalline

5g effervescent powder t.id. during 14 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

60 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients with diagnostic of idiopathic Parkinson disease, with well controlled symptomatology with administration of l-dopa/carbidopa. * At least 3 months of treatment continued of levodopa. * Patients that give the their consent to participate in the study.

Exclusion criteria

* Patients with diagnostic of idiopathic Parkinson disease, with bad controlled symptomatology with administration of l-dopa/carbidopa. * Patients with allergic predisposition to Plantago ovata husk or other contraindications for its use.

Design outcomes

Primary

Measure	Time frame
To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa.	14 days

Secondary

Measure	Time frame
To evaluate if the treatment with Plantago ovata husk modifies the biochemical parameters as total cholesterol, HDL y LDL, glycaemia, etc.	14 days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026