Clinical trial NCT05001217: Chinese Herbal Medicine Treatment as Adjunct Therapy for Parkinson's Disease
Official title: Chinese Herbal Medicine Treatment Based on Subgroup Differentiation as Adjunct Therapy for Parkinson's Disease: a Pilot add-on, Randomised, Controlled, Pragmatic Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Keywords: Chinese medicine
Pragmatic trial
MDS-UPDRS
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2021-08-11
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. diagnosed with PD according to United Kingdom Parkinson's Disease Society Brain Bank (UKPDBB) diagnostic criteria
2. aged 18 to 80 years old
3. under stable ConM treatment with no alteration of dosage in the past 30 days

Exclusion Criteria:

1. secondary PD or atypical parkinsonian disorder
2. used antidepressants in the previous month
3. with concurrent psychiatric, mood, or other neurological disorders
4. suicidal (with suicidal thoughts in the past year)
5. with concurrent severe disorders, such as cancer and myocardial infarction
6. participation in another Chinese herbal medicine clinical study
7. pregnant or breast-feeding
8. Hoehn and Yahr (H\&Y) stage 4 or above
9. liver and renal function derangement

Primary outcomes:
measure: the Movement Disorder Society Sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
timeFrame: from baseline to week 32
Secondary outcomes:
measure: Part I, III and IV as well as the total score of MDS-UPDRS
timeFrame: from baseline to week 32
measure: Non-motor symptom scale
timeFrame: from baseline to week 32
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Medicine, Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Hong Kong Parkinson's Disease Association
Study officials:
affiliation: School of Chinese medicine, Hong Kong Baptist University
name: Min C Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.