None listed
Conditions
Interventions
Others : 1. Treatment Group: pharmacopuncture (PA)
The treatment group will receive SU Eohyeol PA that includes the following nine dried medicinal herbs: Cervi Pantotrichum Cornu and Jungsongouhyul P
Sponsors
Kyung Hee University Oriental Medicine Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with Parkinson disease (1) Adult patients aged =19 years (2) Diagnosis of idiopathic PD based on UK Parkinson’s Diseases Society Brain Bank criteria (3) Hoehn and Yahr Scale stage 1–4 (4) King’s Parkinson’s Disease Pain Scale > 0 (5) A stable dose of conventional treatment for at least 4 weeks prior to enrollment (6) Terminated PA or MA treatment 4 weeks before enrollment (7) Provide voluntary written informed consent to participate in this clinical study Healthy control (1) Adult patients aged =19 years (2) Undiagnosis of idiopathic PD based on UK Parkinson’s Diseases Society Brain Bank criteria (3) No functional/substrate diseases and clinically meaningful findings in medical history investigation and physical examination (4) King’s Parkinson’s Disease Pain Scale = 0 (5) Provide voluntary written informed consent to participate in this clinical study
Exclusion criteria
Exclusion criteria: Patient with Parkinson's disease (1) Parkinson-plus syndromes (i.e., multisystem atrophy, progressive supranuclear palsy, corticobasal degeneration, dementia with Lewy bodies) (2) Pain unrelated to PD (i.e., postoperative pain) (3) History of neuropsychiatric disorder unrelated to PD (4) Moderate or higher cognitive impairment that will interfere with the evaluation of treatment effects (5) Severe acute cardiovascular disease (i.e., heart failure, myocardial infarction, stroke, hypertension) (6) Serious conditions (i.e., anemia, active pulmonary tuberculosis, thyroid disease, and other infectious and systemic diseases) (7) Active cancer (8) Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure >100 mmHg) (9) History of hypersensitivity reactions to the PA (10) Inappropriate or unsafe PA treatment (i.e., hemorrhagic disease, severe diabetes patients who have higher risk of infection) (11) History of oral adrenal corticosteroids (steroids), immunosuppressants, or antipsychotic drug or other drugs that may affect clinical trial results within the last 4 weeks (12) Inability to undergo MRI. (13) Pregnant or lactating women or current contraceptive use among women of pregnant potential who are likely to become pregnant (except for women who have undergone sterilization) (14) History of drug or alcohol abuse (15) Unstable medical condition as decided by the research clinician (16) Participation in another clinical trial within the last 4 weeks (17) History of vaccination within 4 weeks or plans to be vaccinated during the clinical trial period (18) Inappropriate for enrollment due to other reasons as determined by the investigator Healthy control (1) Pain complaint (2) History of neuropsychiatric disorder (3) Moderate or higher cognitive impairment that will interfere with the evaluation of treatment effects (4) Severe acute cardiovascular disease (i.e., heart failure, myocardial infarction, stroke, hypertension) (5) Serious conditions (i.e., anemia, active pulmonary tuberculosis, thyroid disease, and other infectious and systemic diseases) (6) Active cancer (7) Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure >100 mmHg) (8) History of oral adrenal corticosteroids (steroids), immunosuppressants, or antipsychotic drug or other drugs that may affect clinical trial results within the last 4 weeks (9) Inability to undergo MRI. (10) Pregnant or lactating women or current contraceptive use among women of pregnant potential who are likely to become pregnant (except for women who have undergone sterilization) (11) History of drug or alcohol abuse (12) Unstable medical condition as decided by the research clinician (13) Participation in another clinical trial within the last 4 weeks (14) History of vaccination within 4 weeks or plans to be vaccinated during the clinical trial period (15) Inappropriate for enrollment due to other reasons as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| King’s Parkinson’s Disease Pain Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Numeral rating scale ;Unified Parkinson’s Disease Rating Scale II, III ;Beck Depression Inventory II ;Beck Anxiety Inventory ;Pain Catastrophizing score;Euro-Quality of Life-5 Dimension;Parkinson’s disease Sleep Scale -2;King’s Parkinson’s Disease Pain Scale ;Magnetic resonance imaging;Molecular analysis;Pattern identification Questionnaire;Gait analysis;Assessment of facial expressions in response to emotion-eliciting stimuli | — |
Countries
Korea, Republic of
Contacts
Public ContactHye-jin Lee
Kyung Hee University Oriental Medicine Hospital at Gangdong
Outcome results
None listed