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: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Ibadan

Criteria

Inclusion Criteria:

• Willing and able to give informed consent.

• Willingness and ability to comply with study requirements.

• PD diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity, postural instability) being present.

• Age >30 years

• Men and women with mild to moderate PD: Hoehn and Yahr scale stages 1 - 3. Participants may be on current therapeutic agents (including levodopa, dopamine agonists, anticholinergics, amantadine or selegiline) to treat PD symptoms at the time of enrollment and may remain on these agents throughout the 5-month study period.

• Women of childbearing potential (i.e., those not postmenopausal or surgically sterile) may participate provided that they are using adequate birth control methods for the duration of the study. Women of childbearing potential must have a negative pregnancy test at baseline and be non-lactating.

Exclusion Criteria:

• • Subjects with advanced, severe disease, including those with dementia, severe osteoarthritis, allergies, stroke, and visual impairment.

• Presence of atypical PD syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic identified neurogenetic disorders (e.g., Wilson's disease), encephalitis, or other degenerative diseases (e.g., progressive supranuclear palsy).

• Any clinically significant medical condition (e.g., active neoplasm, angina) or laboratory abnormality, which would in the judgement of the investigator interfere with the subjects' ability to participate in the study or be followed