Acupuncture and Moxibustion for Motor Symptoms in Early Parkinson's Disease

NCT ID: NCT06874803

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease (PD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Participants will be unaware of whether they are receiving real or sham acupuncture and moxibustion.

The treating practitioners will follow the same protocol across both groups but will remain blinded to the randomization.

Outcome assessors and statisticians will be blinded to the group assignments during data collection and analysis.

Study Groups

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Acupuncture and Moxibustion Group (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.

Group Type EXPERIMENTAL

Acupuncture and Moxibustion (AM)

Intervention Type PROCEDURE

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 Group (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.

Group Type SHAM_COMPARATOR

Sham Acupuncture and Moxibustion (Sham-AM)

Intervention Type PROCEDURE

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).

Interventions

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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).

Intervention Type PROCEDURE

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).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

Participants meeting any of the following criteria will be excluded:

1. Diagnosed with Parkinson-plus syndromes or other secondary parkinsonism.
2. Prior history of deep brain stimulation (DBS) surgery.
3. Severe cerebrovascular disease, brain trauma, or history of craniotomy.
4. Severe dementia or psychiatric disorders that prevent cooperation with study procedures.
5. Severe coagulation disorders.
6. Presence of severe systemic organ dysfunction (cardiac, pulmonary, hepatic, renal, endocrine, or metabolic disorders).
7. Pregnant or breastfeeding women.
8. History of allergic reaction to acupuncture or moxibustion.
9. Prior treatment with acupuncture or moxibustion within the past three months.
10. Participation in another clinical trial within the past three months.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiani Wu

OTHER

Sponsor Role lead

Responsible Party

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Jiani Wu

Associate Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Guang'anmen Hospita, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu Liu, MD

Role: CONTACT

8572650199

Facility Contacts

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Jiaming Cui

Role: primary

86+18340077036

Other Identifiers

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HLCMHPP2023003

Identifier Type: -

Identifier Source: org_study_id

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