An evaluation of a medicinal herb as a treatment for Parkinson’s disease
Phase 2
- Conditions
- Parkinson´s disease
- Registration Number
- RBR-6t4j85
- Lead Sponsor
- Hospital Universitário Clementino Fraga Filho - UFRJ
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
40 l-dopa treated patients (both genders) with Parkinson’s disease fulfilling the Queen Square Brain Bank Criteria with mild to moderate motor fluctuations will be recruited.
Exclusion Criteria
Demented patients with the Mini Mental Status Examination Score, women of childbearing age and those receiving monoamine oxidase inhibitors or amantidine were excluded.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the safety and descriptive efficacy of Banisteriopsis caapi for the treatment of Parkinson´s disease. Safety will be assessed by means of physical examination and vital signs, collection of adverse events and clinical laboratory tests.Safety results and adverse events will be assessed at every visit.;Change of 5.5 points in total MDS-UPDRS, and MDS-UPDRS motor scores
- Secondary Outcome Measures
Name Time Method MDS-UPDRS dyskinesia score and HADS score change.;Reduction in off time calculated using waking day on-off self scoring diaries based on baseline assessment and twice weekly diary measurement for 4 weeks