Study to Investigate the Effect of Hypoestes Rosea Powder in Parkinson's Disease
Status:
Not yet recruiting
Trial end date:
2021-10-31
Target enrollment:
Participant gender:
Summary
Parkinson's disease (PD) is a progressive neurological disease characterized by resting
tremors, limb stiffness, impaired balance, and slow movement. There is no known cure for PD
although levo-3,4 dihydroxyphenylalanine (L-DOPA) and dopamine agonists are effective for
improving PD symptoms in the early years following diagnosis. Hypoestes rosea is an evergreen
shrub which has anti-inflammatory, anticancer and antimalarial properties. Recent studies
showed that the active pharmaceutical ingredient (API) of Hypoestes rosea, Hypoestoxide, was
effective in modifying disease progression in a transgenic mouse model of PD.
The aim of this study is to determine the efficacy of Hypoestoxide, as contained in Hypoestes
rosea dry leaf powder, in improving motor symptoms in consenting PD patients. The study
design is a double-blind, placebo-controlled cross-over trial involving 30 patients with mild
to moderate disease (Stages 1-3 of Hoehn and Yahr scale over an 8-week period. The symptoms
of the participants will be monitored using mobile phones with an established quantitative
assessment tool, mPower2.0, which was previously developed for monitoring symptoms and
disease progression in PD patients. In addition, the motor examination component of the
International Movement Disorders Society scale will be administered and correlated with the
finding on the mobile phone. The outcome measure is an improvement in the motor variables of
the study participants with a 10% change from baseline over the 8 weeks of using Hypoestes.