Status:
COMPLETED
Study to Investigate the Effect of Hypoestes Rosea Powder in Parkinson's Disease
Lead Sponsor:
University of Ibadan
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-85 years
Phase:
PHASE1
PHASE2
Brief 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 di...
Detailed Description
Justification Age-associated disorders are increasing in many low- and middle-income countries due to population ageing and changing lifestyles. PD is a devastating condition which, in the advanced st...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04858074
Start Date
January 3 2022
End Date
December 31 2022
Last Update
May 9 2023
Active Locations (1)
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1
College of Medicine, University of Ibadan
Ibadan, Oyo State, Nigeria, 200212