A Phase 2/3 interventional study of Conventional medication and Chinese herbal medicine treatment in Parkinson Disease, sponsored by Hong Kong Baptist University. Completed at 2 sites in Hong Kong. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Hong Kong Baptist University · Phase 2/3, Interventional, and Treatment
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).
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 160 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Hong Kong Baptist University is the lead sponsor of 79 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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.
Drug: Conventional medication · Drug: Chinese herbal medicine treatment
Conventional medication for Parkinson's disease include levodopa, dopamine agonist, Monoamine oxidase-B inhibitors, Catechol-O-methyltransferase inhibitors, etc.
Drug: Conventional medication
Levodopa, dopamine agonist, Monoamine oxidase-B inhibitors, Catechol-O-methyltransferase inhibitors, etc.
1. Huanglian Wendan Decoction 2. Jin Gui Shen Qi Pill 3. Liu Wei Di Huang Pill plus Tian Ma Gou Teng Decoction 4. Bu Yang Huan Wu Decoction
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
Time frame: from baseline to week 32
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
Time frame: from baseline to week 32
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)
Time frame: from baseline to week 32
Plan to share: Yes — all IPD that underlie results in a publication, including demographics and characteristics, outcome assessment data, etc
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Hong Kong Baptist University