Parkinson's Disease (PD)WARMEDNCT06874803
Acupuncture and Moxibustion for Motor Symptoms in Early Parkinson's Disease
A study testing Acupuncture and Moxibustion (AM) in people with Parkinson's Disease (PD), run by Jiani Wu at 1 site in China.
Trial summary
This study evaluates the clinical effect and safety of acupuncture combined with moxibustion in improving motor symptoms of early-stage Parkinson's Disease (PD) patients, by assessing the changes in UPDRS scores. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Acupuncture and Moxibustion (AM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- 1. Diagnosed with Parkinson's disease (PD) according to the 2016 Chinese 2. Diagnostic Criteria for Parkinson's Disease.
- 3. Hoehn-Yahr stage <3 (mild to moderate PD). 4. Age between 30 and 80 years (inclusive). 5. Signed informed consent indicating voluntary participation.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Diagnosed with Parkinson-plus syndromes or other secondary parkinsonism.
- Prior history of deep brain stimulation (DBS) surgery.
- Severe cerebrovascular disease, brain trauma, or history of craniotomy.
- Severe dementia or psychiatric disorders that prevent cooperation with study procedures.
- Severe coagulation disorders.
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- Presence of severe systemic organ dysfunction (cardiac, pulmonary, hepatic, renal, endocrine, or metabolic disorders).
- Pregnant or breastfeeding women.
- History of allergic reaction to acupuncture or moxibustion.
- Prior treatment with acupuncture or moxibustion within the past three months.
- Participation in another clinical trial within the past three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospita, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100000
Jiaming Cui, 86+18340077036, Jiaming.cui@foxmail.com
About this study
Official title: Effect of "Qi-Tonifying, Yang-Warming, and Water-Resolving" Acupuncture and Moxibustion for Motor Symptom Improvement in Early Parkinson's Disease (WARMED): A Randomized Controlled Trial
This study evaluates the clinical effect and safety of acupuncture combined with moxibustion in improving motor symptoms of early-stage Parkinson's Disease (PD) patients, by assessing the changes in UPDRS scores. It also explores objective factors affecting the acupuncture effect and investigates the functional MRI mechanisms of acupuncture in PD treatment.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- Acupuncture and Moxibustion (AM), Sham Acupuncture and Moxibustion (Sham-AM)
- Keywords
- Acupuncture, Moxibustion, Parkinson's Disease, Motor Symptoms, Rigidity
- Medical subject headings
- Parkinson Disease, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and Moxibustion (AM)Procedure or surgery
Acupuncture and moxibustion group (AM): Acupuncture at Shuifen (CV9), bilateral Yinlingquan (SP9), bilateral Zhongliao (BL33), and bilateral Weiyang (BL39), combined with moxibustion at Shuifen (CV9) and Zhongliao (BL33).
Sham Acupuncture and Moxibustion (Sham-AM)Procedure or surgery
Sham acupuncture and moxibustion group (sham-AM): Acupuncture at non-acuipoints of bilateral Hegu (LI4) and bilateral Zusanli (ST36), with fake moxibustion at Shuifen (CV9) and bilateral Zhongliao (BL33).
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture and Moxibustion Group (AM) | Experimental | Participants in this group will receive acupuncture and moxibustion therapy alongside standard Parkinson's disease (PD) medication. Acupuncture at Shuifen (CV9), bilateral Yinlingquan (SP9), bilateral Zhongliao (BL33), and bilateral Weiyang (BL39), combined with moxibustion at Shuifen (CV9) and Zhongliao (BL33). Each participant will undergo treatment three times per week for eight weeks (24 total sessions). Standard PD medication will remain unchanged throughout the study. Receives: Procedure: Acupuncture and Moxibustion (AM) |
| Sham Acupuncture and Moxibustion Group (Sham-AM) | Sham comparator | Participants in this group will receive sham acupuncture and sham moxibustion alongside standard PD medication. Acupuncture at non-acuipoints of bilateral Hegu (LI4) and bilateral Zusanli (ST36), with fake moxibustion at Shuifen (CV9) and bilateral Zhongliao (BL33). Treatments will be conducted three times per week for eight weeks (24 total sessions). Standard PD medication will remain unchanged. Receives: Procedure: Sham Acupuncture and Moxibustion (Sham-AM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score change from baseline in the MDS-UPDRS part III after 8-week treatment
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Measured: evaluation time points: baseline, week 8.
Secondary outcomes (13)
The score change from baseline in the MDS-UPDRS part III after 8-week follow-up
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Measured: evaluation time points: baseline, week 16.
Changes in VAS scores of rigidity and bradykinesia after 8-week treatment and 8-week follow-up
The VAS range from 0-10, with higher score indicating more severe symptoms
Measured: evaluation time points: baseline, week 8, week 16.
The score change from baseline in the MDS-UPDRS part II after 8-week treatment and 8-week follow-up
The MDS-UPDRS Part II evaluates the activities of daily living (ADL) in Parkinson's disease patients. It assesses how motor and non-motor symptoms impact daily functioning, including tasks such as dressing, eating, and walking. This section helps in understanding the patient's ability to perform everyday activities. It consists of 13 items, each scored based on the level of difficulty experienced.
Measured: evaluation time points: baseline, week 8, week 16.
The change from baseline in the MDS-UPDRS total score after 8-week treatment and 8-week follow-up
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) is a comprehensive tool used to assess the severity of Parkinson's disease symptoms. It is divided into four parts: motor examination (Part III), activities of daily living (Part II), non-motor experiences of daily living (Part I), and motor complications (Part IV). This scale helps in tracking disease progression, evaluating treatment efficacy, and improving clinical decision-making.
Measured: evaluation time points: baseline, week 8, week 16.
The proportion of participants with ≥30% decrease of MDS-UPDRS Part III after 8-week treatment and 8-week follow-up
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Measured: evaluation time points: baseline, week 8, week 16.
The change from baseline in PDQ-39 after 8-week treatment and 8-week follow-up
The PDQ-39 (Parkinson's Disease Questionnaire-39) is a patient-reported outcome measure used to assess the health-related quality of life in Parkinson's disease patients. It includes 39 items covering eight domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and sleep. Each item is scored based on the degree of difficulty or discomfort, and the results are summarized to provide an overall score. Higher scores indicate greater impairment in quality of life.
Measured: evaluation time points: baseline, week 8, week 16.
The change from baseline in PDSS after 8-week treatment and 8-week follow-up
The Parkinson's Disease Sleep Scale (PDSS) is a tool used to assess sleep disturbances in Parkinson's disease patients. It consists of 15 items, covering sleep quality, nighttime symptoms, and daytime sleepiness. Each item is rated on a scale from 0 to 4, with higher scores indicating more severe sleep problems. The total score helps to evaluate the overall impact of sleep disturbances on the patient's quality of life.
Measured: evaluation time points: baseline, week 8, week 16.
The change from baseline in SDS after 8-week treatment and 8-week follow-up
The Self-Rating Depression Scale (SDS) is a tool used to assess the severity of depressive symptoms. It consists of 20 items, each addressing mood, behavior, and physical symptoms related to depression. Each item is scored on a 4-point scale, ranging from "none" to "severe." Higher total scores indicate more severe depressive symptoms, helping to assess the patient's mental health status.
Measured: evaluation time points: baseline, week 8, week 16.
The change from baseline in SAS after 8-week treatment and 8-week follow-up
The Self-Rating Anxiety Scale (SAS) is a tool used to assess the severity of anxiety symptoms. It consists of 20 items, which evaluate physical and psychological symptoms of anxiety. Each item is scored on a 4-point scale, from "none" to "severe." Higher total scores indicate greater levels of anxiety, helping to gauge the patient's emotional and mental state.
Measured: evaluation time points: baseline, week 8, week 16.
The change from baseline in functional MRI signals after 8-week treatment.
The hospital's radiology department uses functional magnetic resonance imaging (fMRI) to measure and map brain activity by detecting changes in blood oxygen level-dependent (BOLD) signals in different brain regions.
Measured: evaluation time points: baseline, week 8.
Subgroup analysis of gender in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
Stratifying by gender into male and female subgroups, we assessed the difference in MDS-UPDRS Part III scores within each subgroup to compare the efficacy between men and women. The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Measured: evaluation time points: baseline, week 8.
Subgroup analysis of age in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
Age stratification was performed by dividing participants into two subgroups: those younger than 60 years and those aged 60 and above. The difference in MDS-UPDRS Part III scores was assessed within each subgroup to compare the treatment efficacy between the two age subgroups. The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Measured: evaluation time points: baseline, week 8.
Subgroup analysis of disease severity in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
Patients were stratified based on disease severity using the Hoehn and Yahr staging system into four subgroups: stage 1, 1.5, 2, and 2.5. The efficacy differences across disease stages were assessed by evaluating the change in MDS-UPDRS Part III scores within each subgroup. The difference in MDS-UPDRS Part III scores was assessed within each subgroup to compare the treatment efficacy between the two age subgroups. The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Measured: evaluation time points: baseline, week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Aug 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiani Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiani Wu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874803
- Sponsor's protocol ID
- HLCMHPP2023003
- Acronym
- WARMED
- Status last verified
- Jul 2025
- First submitted
- 24 Feb 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared, including all IPD that underlie the results reported in future publications. The data will include demographic information, clinical assessments, MDS-UPDRS scores, VAS scores, PDQ-39 scores, PDSS scores, SAS/SDS scores, and fMRI imaging data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of "Qi-Tonifying, Yang-Warming, and Water-Resolving" Acupuncture and Moxibustion for Motor Symptom Improvement in Early Parkinson's Disease (WARMED): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06874803
- Acronym / sponsor ID
- WARMED / HLCMHPP2023003
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Acupuncture, Moxibustion, Parkinson's Disease, Motor Symptoms, Rigidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiani WuUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the clinical effect and safety of acupuncture combined with moxibustion in improving motor symptoms of early-stage Parkinson's Disease (PD) patients, by assessing the changes in UPDRS scores. It also explores objective factors affecting the acupuncture effect and investigates the functional MRI mechanisms of acupuncture in PD treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture and Moxibustion Group (AM) | Experimental | Procedure: Acupuncture and Moxibustion (AM)Participants in this group will receive acupuncture and moxibustion therapy alongside standard Parkinson's disease (PD) medication. Acupuncture at Shuifen (CV9), bilateral Yinlingquan (SP9), bilateral Zhongliao (BL33), and bilateral Weiyang (BL39), combined with moxibustion at Shuifen (CV9) and Zhongliao (BL33). Each participant will undergo treatment three times per week for eight weeks (24 total sessions). Standard PD medication will remain unchanged throughout the study. |
| Sham Acupuncture and Moxibustion Group (Sham-AM) | Sham comparator | Procedure: Sham Acupuncture and Moxibustion (Sham-AM)Participants in this group will receive sham acupuncture and sham moxibustion alongside standard PD medication. Acupuncture at non-acuipoints of bilateral Hegu (LI4) and bilateral Zusanli (ST36), with fake moxibustion at Shuifen (CV9) and bilateral Zhongliao (BL33). Treatments will be conducted three times per week for eight weeks (24 total sessions). Standard PD medication will remain unchanged. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Diagnosed with Parkinson's disease (PD) according to the 2016 Chinese 2. Diagnostic Criteria for Parkinson's Disease.
- 3. Hoehn-Yahr stage <3 (mild to moderate PD). 4. Age between 30 and 80 years (inclusive). 5. Signed informed consent indicating voluntary participation.
Key exclusion criteria (11 listed)
- Diagnosed with Parkinson-plus syndromes or other secondary parkinsonism.
- Prior history of deep brain stimulation (DBS) surgery.
- Severe cerebrovascular disease, brain trauma, or history of craniotomy.
- Severe dementia or psychiatric disorders that prevent cooperation with study procedures.
- Severe coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture and Moxibustion (AM)Acupuncture and moxibustion group (AM): Acupuncture at Shuifen (CV9), bilateral Yinlingquan (SP9), bilateral Zhongliao (BL33), and bilateral Weiyang (BL39), combined with moxibustion at Shuifen (CV9) and Zhongliao (BL33). | Procedure or surgery | Acupuncture and Moxibustion Group (AM) |
| Sham Acupuncture and Moxibustion (Sham-AM)Sham acupuncture and moxibustion group (sham-AM): Acupuncture at non-acuipoints of bilateral Hegu (LI4) and bilateral Zusanli (ST36), with fake moxibustion at Shuifen (CV9) and bilateral Zhongliao (BL33). | Procedure or surgery | Sham Acupuncture and Moxibustion Group (Sham-AM) |
Primary outcome
The score change from baseline in the MDS-UPDRS part III after 8-week treatment
Time frame: evaluation time points: baseline, week 8.
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
13 secondary outcomes
The score change from baseline in the MDS-UPDRS part III after 8-week follow-up
Time frame: evaluation time points: baseline, week 16.
Changes in VAS scores of rigidity and bradykinesia after 8-week treatment and 8-week follow-up
Time frame: evaluation time points: baseline, week 8, week 16.
The score change from baseline in the MDS-UPDRS part II after 8-week treatment and 8-week follow-up
Time frame: evaluation time points: baseline, week 8, week 16.
The change from baseline in the MDS-UPDRS total score after 8-week treatment and 8-week follow-up
Time frame: evaluation time points: baseline, week 8, week 16.
The proportion of participants with ≥30% decrease of MDS-UPDRS Part III after 8-week treatment and 8-week follow-up
Time frame: evaluation time points: baseline, week 8, week 16.
The change from baseline in PDQ-39 after 8-week treatment and 8-week follow-up
Time frame: evaluation time points: baseline, week 8, week 16.
The change from baseline in PDSS after 8-week treatment and 8-week follow-up
Time frame: evaluation time points: baseline, week 8, week 16.
The change from baseline in SDS after 8-week treatment and 8-week follow-up
Time frame: evaluation time points: baseline, week 8, week 16.
The change from baseline in SAS after 8-week treatment and 8-week follow-up
Time frame: evaluation time points: baseline, week 8, week 16.
The change from baseline in functional MRI signals after 8-week treatment.
Time frame: evaluation time points: baseline, week 8.
Subgroup analysis of gender in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
Time frame: evaluation time points: baseline, week 8.
Subgroup analysis of age in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
Time frame: evaluation time points: baseline, week 8.
Subgroup analysis of disease severity in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
Time frame: evaluation time points: baseline, week 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared, including all IPD that underlie the results reported in future publications. The data will include demographic information, clinical assessments, MDS-UPDRS scores, VAS scores, PDQ-39 scores, PDSS scores, SAS/SDS scores, and fMRI imaging data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Moxibustion (AM) in people with Parkinson's Disease (PD), run by Jiani Wu at 1 site in China.
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 11 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: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Liu, MD (8572650199, yliu133@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score change from baseline in the MDS-UPDRS part III after 8-week treatment (time frame: evaluation time points: baseline, week 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2025.