Study to Investigate the Effect of Hypoestes Rosea Powder in Parkinson's Disease

NCT04858074 | Completed Phase 1 DMC

• 1 other identifier: UI/EC/20/0320
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Parkinson Disease

Keywords

Motor symptoms; Hoehn and Yahr Stages 1-3; Hypoestes; Sub-Saharan Africa

Outcome Measures

Primary Outcomes (1)

• motor manifestations

  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

  eight weeks

Study Arms (2)

Active medication- PECKO-D

EXPERIMENTAL

Participants will be randomly allocated to experimental drug

Drug: Hypoestoxide

Placebo

PLACEBO COMPARATOR

Corn-Starch will be administered as placebo agent

Drug: Hypoestoxide

Interventions

Hypoestoxide DRUG

Its active pharmaceutical ingredient (API) is Hypoestoxide, discovered in 1983, which was recently shown to be active against alpha synuclein and was very effective in modifying disease progression in a transgenic mouse model of PD

Also known as: PECKO-D forte

Active medication- PECKO-D; Placebo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ibadan: lead

Study Sites (1)

College of Medicine, University of Ibadan

Ibadan, Oyo State, 200212, Nigeria

Location

Related Publications (1)

• Olalusi OV, Oguntiloye OO, Makanjuola AI, Yaria JO, Chukwuocha I, Akinyemi RO, Ogunniyi A. Assessing the Efficacy of Peko-D Forte as Add-on Therapy for Parkinson's Disease: A Proof of Concept, Double-Blind, Placebo-Controlled Study. West Afr J Med. 2025 Jan 30;42(1):61-66.

  PMID: 40548419 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

hypoestoxide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Adesola Ogunniyi, MD

  College of Medicine, University of Ibadan, Nigeria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Data recorded by computer application remotely. Investigator will not be aware of patient group; the active and placebo medications are alike
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double-blind, placebo-controlled cross-over study

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 26, 2021
• Study Start: January 3, 2022
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Immediately data analysis is completed and for the next 12 months
• Access Criteria: participants, research collaborators, monitoring and evaluation team

Locations

NG (1)