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NCT Number: NCT05001217

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

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).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Medicine, Queen Elizabeth Hospital, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

conventional medication

Drug

Levodopa, dopamine agonist, Monoamine oxidase-B inhibitors, Catechol-O-methyltransferase inhibitors, etc.

Chinese herbal medicine treatment

Drug
  • Huanglian Wendan Decoction
  • Jin Gui Shen Qi Pill
  • Liu Wei Di Huang Pill plus Tian Ma Gou Teng Decoction
  • Bu Yang Huan Wu Decoction

Primary outcomes

  1. the Movement Disorder Society Sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II

    Time frame: from baseline to week 32

    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

Secondary outcomes

  1. Part I, III and IV as well as the total score of MDS-UPDRS

    Time frame: from baseline to week 32

    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

  2. Non-motor symptom scale

    Time frame: from baseline to week 32

    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)

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Collaborators

  • Chinese University of Hong Kong

Registry information

Official study 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

Acronym: HERB-PARK

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 11, 2021
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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