Chinese Herbal Medicine Treatment Based on Subgroup Differentiation as Adjunct Therapy for Parkinson's Disease: a Pilot add-on, Randomised, Controlled, Pragmatic Clinical Trial

• Status: Not yet recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Background: Parkinson's disease (PD) is a prevalent and debilitating condition. The numerous symptoms incurred by PD greatly lowers patients' quality of life and their self-care ability. Conventional medications cannot control all symptoms yet inflict adverse effects. Observational study reported that Chinese herbal medicine (CHM) is frequently sought by PD patients. However, clinical evidence on the effect of CHM is conflicted and low in quality. This trial aims to explore the effect of CHM incorporating pattern subgroup differentiation in treating PD symptoms.

Objectives: To explore the effect of CHM on PD parameters, including symptom severity and quality of life, by utilizing a Chinese medicine (CM) pattern diagnostic and treatment guideline.

Methods: This trial is a pilot assessor-blind, add-on, randomised, controlled, pragmatic clinical trial. 160 PD patients will be recruited and randomised into treatment or control group in a 1:1 ratio. Patients in treatment group will receive a 32-week CHM treatment based on CM pattern differentiation on top of their conventional medication (ConM), while control group will receive ConM only. The primary outcome is part II of the Movement Disorder Society Sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS), which assesses motor-related quality of life. Secondary outcomes include part and total scores of MDS-UPDRS, domain and total scores of Non-motor symptom scale (NMSS), and the pattern assessment in Guiding Principle of Clinical Research on New Drugs of Chinese Medicine. Adverse events will be monitored by monthly follow-ups and questionnaires. Data analysis will be conducted using Jamovi or R.

Ethical approval: Ethical clearance of this study is given by the Research Ethics Committee of Hong Kong Baptist University (reference number: REC/20-21/0206).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hong Kong Baptist University
• Collaborator: Chinese University of Hong Kong

Criteria

Inclusion Criteria:

1. diagnosed with PD according to United Kingdom Parkinson's Disease Society Brain Bank (UKPDBB) diagnostic criteria

2. 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. history of psychiatric, mood, or other neurological disorders

4. suicidal (with suicidal thoughts in the past year)

5. history of severe diseases, such as cancer and myocardial infarction

6. participation in another clinical study

7. pregnant or breast-feeding

8. Hoehn and Yahr (H&Y) stage 4 or above

9. deranged liver and renal function