None listed
Conditions
Interventions
Drug : Yokukansankachimpihange(Atractylodis rhizoma, Poria sclerotium, Cnid-ium rhizome, Uncaria thorn, Japanese Angelica root, Bupleurum root, Glycyrrhiza, Citrus, and Pinellia ternata) or placebo dr
Sponsors
Dunsan Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) K-FRAIL scale ? 1 (2) STAI ? 41 (for man), STAI ? 42 (for woman) (3) SCOPA -night score ? 7 (4) A diagnosis of PD made by a neurologist (5) Patients who corresponds to Hoehn and Yahr scale stage 1–4 (6) Patients who voluntarily participated in the trial and Informed consent completed
Exclusion criteria
Exclusion criteria: (1) Patients with Alzheimer’s dementia, vascular dementia, Huntington's disease, Amyotrophic lateral sclerosis or hydrocephalus (2) Gait disturbance caused by stroke, brain tumor, or other brain disease (3) A diagnosis of gastrointestinal disease, endocrine disease, or cardiovascular disease not controlled by diet or medication - Persons with a history of gastrointestinal disorders (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of the test drug. - Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. (4) AST or ALT exceeds twice the upper limit of the reference range or the total bilirubin exceeds twice the upper limit of the reference range (5) Kidney disease such as kidney dialysis (liver cancer, cirrhosis, chronic kidney failure, congestive heart failure, etc.) (6) Unstable medical condition as decided by the research clinician (7) If the attending physician determines that there is a significant physical or mental deficiency that does not understand and can not follow the overall treatment (8) Take a herb medication for PD within the last 4 weeks (9) Clinical laboratory abnormality such as serum creatinine =97mmol/L, alanine amino transferase =40U/L, aspartate amino transferase =40U/L) (10) Inability to undergo fNIRS (11) According to the researcher's judgment, patients who are not eligible to participate in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Questionnaire survey assessing sleep problems : SCOPA-S (Scales for Outcomes in PD-Sleep Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire survey associating sleep problems: PDSS (Parkinson’s disease Sleep Scale), ESS (Epworth sleep scale), STAI (State-Trait Anxiety Inventory), BDI (Beck Depression Inventory), PSS (Perceived Stress Scale), Fatigue, resistance, ambulation, illnesses, and loss of weight scale (K-FRAIL);Polysomnography and hormone analysis (cortison and melatonin);Measurement on hemodynamic change in prefrontal cortex using fNIRS;Analysis of Neurotransmitters in blood: Neurotransmitters related to Parkinson's disease include dopamine, 41 amino acids (including glutamate, GABA), Norepinephrine, Epinephrine, serotonin;mRAN analysis | — |
Countries
Korea, Republic of
Contacts
Public ContactJung-Hee Jang
Dunsan Korean Medicine Hospital of Daejeon University
Outcome results
None listed