Chinese Herbal Medicine Treatment as Adjunct Therapy for Parkinson's Disease

Parkinson Disease Clinical Trial

— HERB-PARK  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05001217
• Other study ID #: HKBU
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2023
• Source: Hong Kong Baptist University
• Contact: Min Li, PhD
• Phone: 3411 2919
• Email: limin[@]hkbu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Conventional medication
Levodopa, dopamine agonist, Monoamine oxidase-B inhibitors, Catechol-O-methyltransferase inhibitors, etc.
• Chinese herbal medicine treatment
Huanglian Wendan Decoction Jin Gui Shen Qi Pill Liu Wei Di Huang Pill plus Tian Ma Gou Teng Decoction Bu Yang Huan Wu Decoction

Locations

Country	Name	City	State
Hong Kong	Department of Medicine, Queen Elizabeth Hospital	Hong Kong
Hong Kong	Hong Kong Parkinson's Disease Association	Hong Kong

Sponsors (2)

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

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Part I, III and IV as well as the total score of MDS-UPDRS	Comprehensively assesses motor, non motor, and motor complications of Parkinson's patients Scale (Higher the score, the more severe the condition or symptom): Scale: 0: Normal, 1: Slight, 2: Mild, 3: Moderate, 4: Severe	from baseline to week 32
Secondary	Non-motor symptom scale	Assesses in details the severity of non motor symptoms of Parkinson's Scale (Higher the score, the more severe the condition or symptom): Severity: 0 = None, 1= Mild (symptoms present but causes little distress or disturbance to patient), 2 = Moderate (some distress or disturbance to patient), 3 = Severe (major source of distress or disturbance to patient); Frequency: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time)	from baseline to week 32