Chinese Herbal Medicine Treatment as Adjunct Therapy for Parkinson's Disease (HERB-PARK)

Hong Kong Baptist University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Chinese herbal medicine treatment; Drug: Conventional medication

Study type: Interventional

Funder types: Other

Identifiers

NCT05001217

HKBU

Details and patient eligibility

About

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).

Enrollment: 160 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Chinese herbal medicine treatment plus conventional medication

Experimental group

Description:

Participants 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.

Treatment:

Drug: Conventional medication

Drug: Chinese herbal medicine treatment

Conventional medication

Active Comparator group

Description:

Conventional medication for Parkinson's disease include levodopa, dopamine agonist, Monoamine oxidase-B inhibitors, Catechol-O-methyltransferase inhibitors, etc.

Treatment:

Drug: Conventional medication