A Proof of Concept (POC) Study to Investigate the Effect of 100% Hypoestes Rosea Powder in Parkinson's Disease Using ActiGraph Wearable as a Quantitative Assessment Tool.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- motor manifestations
研究概览
简要总结
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.
详细描述
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 stages, is associated with immobility and uncontrollable tremors. Life then becomes miserable for the sufferers. Unfortunately, there is no cure for the disease except control of symptoms with medications. Any treatment combination that leads to better symptom control will go a long way in improving the quality of life for PD patients. This proof-of-concept study (POC), if successful will give a new lease on life to PD patients. Hence it is considered worthwhile to treat PD patients with a new compound that is contained in a local plant that is readily available and holds promise for efficacy based on its mode of action specifically in reducing the formation of alpha synuclein which underlies the neuronal death in PD.
OBJECTIVES OF THE STUDY
The aim of this study is to determine the efficacy of Hypoestoxide, as contained in Hypoestes rosea dry leaf powder (PECKO-D), in improving motor symptoms in consenting PD patients over an 8-week period.
Specific Objectives:
• To determine the efficacy of Hypoestes rosea in improving motor performance of PD patients through traditional clinical evaluation, use of the selected components of the Motor Examination section of the International Movement Disorders Society Scale and ActiGraph wearable as a quantitative assessment tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Data recorded by computer application remotely. Investigator will not be aware of patient group; the active and placebo medications are alike
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
- •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.
排除标准
- •• 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
研究组 & 干预措施
Active medication- PECKO-D
Participants will be randomly allocated to experimental drug
干预措施: Hypoestoxide (Drug)
Placebo
Corn-Starch will be administered as placebo agent
干预措施: Hypoestoxide (Drug)
结局指标
主要结局
motor manifestations
时间窗: eight weeks
10% Mean change in motor assessment parameters using the International Movement Disorders Society Scale - selected motor examination items while on the Hypoestes. This equates to 1- to 2-point improvement in motor performance over a 2-month period
次要结局
未报告次要终点
研究者
ADESOLA OGUNNIYI
Professor
University of Ibadan