Meridian Activation Remedy System for Parkinson's Disease

NCT ID: NCT05621772

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2025-07-31

Brief Summary

In this study, the investigators aim to evaluate the clinical efficacy and cost-effectiveness of MARS-PD. Conventional, usual care will be used as the comparator because this trial aims to assess the add-on effect of MARS-PD. The investigators hypothesize that the complex therapy will relieve motor and nonmotor symptoms, improve gait performance, and enhance neuroplasticity in PD patients, and will be safe and cost-effective.

Detailed Description

This study is a randomized controlled trial conducted at a single center with raters blinded to the intervention. We will look at the clinical effect of MARS-PD, consisting of 16 interventions over an 8-week period, in 88 individuals with Parkinson's disease. Patients will be assigned to either the experimental (n=44) or control (n=44) groups at random. he experimental group will receive the MARS intervention, while the control group will receive usual care only. The treatment duration is 8 weeks, followed by a 12-week follow-up. The primary outcome is the change in MDS-UPDRS Part III (Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III) score from baseline to 8 weeks. Secondary outcomes include assessments such as MDS-UPDRS, International Physical Activity Questionnaire Short Form, Parkinson Self Questionnaire, Parkinson's Disease Sleep Scale, Timed Up and Go test, GAITRite metrics, Functional Near-Infrared Spectroscopy measurements, smart band results, gut microbiome composition and diversity, and iris connective tissue texture.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group (Meridian Activation Remedy System for Parkinson's Disease)

Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) treatment (16 times/8 weeks total, 2 times/week)

Group Type: EXPERIMENTAL

Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)

Intervention Type: OTHER

MARS-PD is a complex therapy developed by researchers to enhance the synergistic effects of acupuncture and exercise.

Control group (Usual Care)

Usual care (all participants will be allowed to continue their prescribed medication and treatment (except Korean Medicine therapy), and they will not receive any additional treatment or therapy in the research institute), and lifestyle advice (all participants will receive a smart band and application-based guidance about their lifestyle)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)

MARS-PD is a complex therapy developed by researchers to enhance the synergistic effects of acupuncture and exercise.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 45 to 75 years of age

2. Patients with PD, diagnosed according to the United Kingdom Parkinson's Diseases Society Brain Bank Criteria

3. Hoehn and Yahr scale stage I to III

4. Patients who have voluntarily decided to participate in the clinical study and signed the informed consent form

Exclusion Criteria

1. Clinically unstable patients (e.g., elevated aspartate transaminase (AST) or alanine aminotransferase (ALT) more than three-fold the upper limit of normal in the research institute's laboratory, heart failure, respiratory failure, etc.)

2. Patients who are planning to undergo deep brain stimulation within the study period

3. Pregnant or lactating women

4. Patients with MMSE-K (Mini-Mental State Exam) score of 18 or less

5. If there has been a change in the dosage of antiparkinsonian drugs (e.g., L-dopa, COMT (catechol-O-methyltransferase) inhibitor, Dopamine agonist, MAO-B (monoamine oxidase B) inhibitor, etc.) according to a doctor's prescription within the last 4 weeks prior to enrollment

6. Patients who are receiving manual therapy, exercise therapy, or rehabilitation therapy for Parkinson's disease according to a doctor's prescription within the last 4 weeks prior to enrollment, or are planning to receive such therapy within the study period

7. Patients who are not suitable for participation in this clinical study according to the judgment of the researcher

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

HoRyong Yoo

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ho Ryong Yoo, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Daejeon University

Locations

Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University

Daejeon, , South Korea

Countries

South Korea

References

Park MS, Park S, Kang JY, Jung IC, Yoo H. The efficacy and safety of MARS-PD: Meridian activation remedy system for Parkinson's disease-A single-center, assessor and statistician-blinded, parallel-group randomized, controlled trial protocol. PLoS One. 2024 May 6;19(5):e0303156. doi: 10.1371/journal.pone.0303156. eCollection 2024.

Reference Type: DERIVED

PMID: 38709746 (View on PubMed)

Other Identifiers

DJ_PD_21_02

Identifier Type: -

Identifier Source: org_study_id