An evaluation of a medicinal herb as a treatment for Parkinson’s disease

A phase 2, double-blind, randomized, controlled trial of the safety and efficacy of Banisteriopsis caapi versus placebo in patients with Parkinson´s disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-6t4j85

Enrollment

Unknown

Registered

2018-09-10

Start date

2018-09-02

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Parkinson´s disease

Interventions

1. Patients 40 l-dopa treated patients with Parkinson’s disease (both genders, aged 50 to 70 years) fulfilling the Queen Square Brain Bank Criteria with mild to moderate motor fluctuations will be re

Other

E02.190.755

Eligibility

Age

50 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Brazil

Contacts

Public ContactAna Lucia Zuma de Rosso

Hospital Universitário Clementino Fraga Filho - UFRJ

anarosso@gmail.com+552199426319

Outcome results

None listed

Source: REBEC (via WHO ICTRP)