Chinese Herbal Medicine Treatment as Adjunct Therapy for Parkinson's Disease
HERB-PARK
1 other identifier
interventional
160
1 country
2
Brief Summary
Background: Parkinson's disease (PD) is a prevalent and debilitating condition. Conventional medications cannot control all symptoms and may inflict adverse effects. A survey reported that Chinese herbal medicine (CHM) is frequently sought. Existing CHM trials were contradictory and often of poor quality due to a lack of methodological rigor. A national clinical guideline was drafted in China with diagnostic criteria and treatment strategy of Chinese medicine (CM) patterns subgroups of PD. The suggested CHM was found to exhibit a neuroprotective effect in in vitro and in vivo studies. This trial aims to preliminarily assess the effect of CHM prescribed based on pattern differentiation on PD symptoms and patients' quality of life, and evaluate the feasibility of the trial design for a future large-scale trial. Methods: This trial will be a pilot assessor- and data analyst blind, add-on, randomised, controlled, pragmatic clinical trial. 160 PD patients will be recruited and randomised into treatment or control groups in a 1:1 ratio. The trial will be conducted over 32 weeks. PD patients in the treatment group will be stratified into subgroups based on CM pattern and receive CHM accordingly in addition to conventional medication (ConM). The control group will receive ConM only. The primary outcome will be part II of the Movement Disorder Society Sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Secondary outcomes will include part and total scores of MDS-UPDRS, domain and total scores of Non-motor symptom scale (NMSS). Adverse events will be monitored by monthly follow-ups and questionnaires. Mixed models will be used to analyse data by Jamovi and R. Expected outcomes: The success of our trial will show that the pragmatic design with subgroup differentiation is feasible and can produce reliable results. It will also provide preliminary data of the effect of CHM on improving clinical outcomes and quality of PD patients. Data collected will be used to optimize the study design of the future large-scale clinical study. Ethical clearance: Ethical clearance of this study was given by the Research Ethics Committee of Hong Kong Baptist University (REC/20-21/0206).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 parkinson-disease
Started Jan 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2021
CompletedFirst Posted
Study publicly available on registry
August 11, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedOctober 8, 2024
January 1, 2023
2 years
July 7, 2021
October 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the Movement Disorder Society Sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
Assesses the self-reported motor experience of the daily living of Parkinson's patients Scale (Higher the score, the more severe the condition or symptom): 0: Normal, 1: Slight, 2: Mild, 3: Moderate, 4: Severe
from baseline to week 32
Secondary Outcomes (2)
Part I, III and IV as well as the total score of MDS-UPDRS
from baseline to week 32
Non-motor symptom scale
from baseline to week 32
Study Arms (2)
Chinese herbal medicine treatment plus conventional medication
EXPERIMENTALParticipants will receive integrated medicine treatment combining Chinese herbal treatment, given in the form of granules, and conventional medication for 32 weeks. Patients will be differentiated into 4 subgroups based on their Chinese medicine pattern, and receive herbal treatment accordingly. An existing clinical pathway will guide the diagnosis and treatment of the Chinese medicine patterns. The four pattern subgroups are as follows: 1\) the "Phlegm-heat stirring Wind" subgroup; 2) the "Spleen-and Kidney-Yang" subgroup; 3) the "Internal Stirring of Yang and Wind" subgroup; and 4) the "Qi deficiency and stasis of Blood" subgroup To resemble actual clinical practice, minor adjustment of herbal treatment will be possible and also adhere to the mentioned clinical guideline. The dosage of each herbal drug will follow the instructions of China Pharmacopeia.
Conventional medication
ACTIVE COMPARATORConventional medication for Parkinson's disease include levodopa, dopamine agonist, Monoamine oxidase-B inhibitors, Catechol-O-methyltransferase inhibitors, etc.
Interventions
Levodopa, dopamine agonist, Monoamine oxidase-B inhibitors, Catechol-O-methyltransferase inhibitors, etc.
1. Huanglian Wendan Decoction 2. Jin Gui Shen Qi Pill 3. Liu Wei Di Huang Pill plus Tian Ma Gou Teng Decoction 4. Bu Yang Huan Wu Decoction
Eligibility Criteria
You may qualify if:
- diagnosed with PD according to United Kingdom Parkinson's Disease Society Brain Bank (UKPDBB) diagnostic criteria
- aged 18 to 80 years old
- under stable ConM treatment with no alteration of dosage in the past 30 days
You may not qualify if:
- secondary PD or atypical parkinsonian disorder
- used antidepressants in the previous month
- with concurrent psychiatric, mood, or other neurological disorders
- suicidal (with suicidal thoughts in the past year)
- with concurrent severe disorders, such as cancer and myocardial infarction
- participation in another Chinese herbal medicine clinical study
- pregnant or breast-feeding
- Hoehn and Yahr (H\&Y) stage 4 or above
- liver and renal function derangement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hong Kong Baptist Universitylead
- Chinese University of Hong Kongcollaborator
Study Sites (2)
Department of Medicine, Queen Elizabeth Hospital
Hong Kong, Hong Kong
Hong Kong Parkinson's Disease Association
Hong Kong, Hong Kong
Related Publications (1)
Yuen SCS, Chua KK, Zhong LLD, Chan KW, Chan CKH, Chan KL, Lin Z, Mok V, Lau AY, Li M. Chinese herbal medicine treatment based on subgroup differentiation as adjunct therapy for Parkinson's disease: study protocol of a pilot add-on, randomised, controlled, pragmatic clinical trial. Chin Med. 2022 Jan 24;17(1):16. doi: 10.1186/s13020-022-00572-0.
PMID: 35073963DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min C Li, PhD
School of Chinese medicine, Hong Kong Baptist University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2021
First Posted
August 11, 2021
Study Start
January 1, 2022
Primary Completion
December 31, 2023
Study Completion
January 31, 2024
Last Updated
October 8, 2024
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- from baseline to week 32
all IPD that underlie results in a publication, including demographics and characteristics, outcome assessment data, etc