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Parkinson DiseasePhase 2/3HERB-PARKNCT05001217

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

A Phase 2/3 study testing Conventional medication and Chinese herbal medicine treatment in people with Parkinson Disease, run by Hong Kong Baptist University at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Conventional medication and Chinese herbal medicine treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
2 sitesHong Kong
Study dates
1 Jan 2022to 31 Jan 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • pregnant or breast-feeding
  • Hoehn and Yahr (H\&Y) stage 4 or above
  • liver and renal function derangement

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

  • Department of Medicine, Queen Elizabeth Hospital

    Hong Kong

  • Hong Kong Parkinson's Disease Association

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read more

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).

Being tested
Conventional medication, Chinese herbal medicine treatment
Keywords
Chinese medicine, Pragmatic trial, MDS-UPDRS
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional medicationDrug

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

  • Chinese herbal medicine treatmentDrug

    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
Study groups in NCT05001217
Study groupRoleWhat they receive
Chinese herbal medicine treatment plus conventional medicationExperimentalParticipants 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.
Receives: Drug: Conventional medication; Drug: Chinese herbal medicine treatment
Conventional medicationActive comparatorConventional medication for Parkinson's disease include levodopa, dopamine agonist, Monoamine oxidase-B inhibitors, Catechol-O-methyltransferase inhibitors, etc.
Receives: Drug: Conventional medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: from baseline to week 32

Secondary outcomes (2)

  1. 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

    Measured: from baseline to week 32

  2. 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)

    Measured: from baseline to week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2021
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2023
  4. Study completion31 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05001217
Sponsor's protocol ID
HKBU
Acronym
HERB-PARK
Status last verified
Jan 2023
First submitted
7 Jul 2021
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication, including demographics and characteristics, outcome assessment data, etc

Publications

  • Yuen SCS, Chua KK, Zhong LLD, Chan KW, Chan CKH, Chan KL, Lin Z, Mok V, Lau AY, Li M. Chinese herbal medicine treatment based on subgroup differentiation as adjunct therapy for Parkinson's disease: study protocol of a pilot add-on, randomised, controlled, pragmatic clinical trial. Chin Med. 2022 Jan 24;17(1):16. doi: 10.1186/s13020-022-00572-0.

    PubMed 35073963

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Conventional medication and Chinese herbal medicine treatment in people with Parkinson Disease, run by Hong Kong Baptist University at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the Movement Disorder Society Sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (time frame: from baseline to week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05001217, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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