None listed
Conditions
Interventions
Drug : In the treatment group, 4 g of HH368 (Eoggansangahubagjisil 4g) is administered twice a day (8 g) for a total of 42 days, and acupuncture and physician consultation will be offered twice a week
Sponsors
KyungHee University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 45 to over 80 2) Those who have been diagnosed with idiopathic Parkinson's disease and have been on levodopa for more than 5 years 3) Hoehn & Yahr stage 2-3 4) Those who have no cognitive problems and have voluntarily agreed to participate in the test after written informed consent
Exclusion criteria
Exclusion criteria: 1) Diagnosed with secondary Parkinson's syndrome or atypical Parkinsonian syndrome 2) Diseases that may affect the adminitration or absorption of drugs (swallowing disorders, clinically severe digestive disorders, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.) 3) Those who have a history of serious heart disease such as myocardial infarction or heart failure 4 )Those who have had deep brain stimulation 5) Those who have a history of allergy to the test drug 6 )Those who have a history of liver disease or kidney disease, or AST, ALT, BUN or Creatinine exceeds 3 times over the normal upper limit 7) Women who have pregnancy plan, are pregnant or breastfeeding 8) Those who have participated in another test within 30 days before participating in the clinical trial 9) Those who are judged that participation is difficult due to clinically significant psychiatric symptoms, medical illnesses, laboratory findings, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change score of total Movement disorder society-unified Parkinson's disease rating scale (MDS-UPDRS) score between before treatment (V1) and after 6-week of treatment (V13) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change trends of total MDS-UPDRS score, MDS-UPDRS part ?, ?, ?, ? score before treatment (V1), after 6-week of treatment and follow up at 12 weeks (V14);Change scores in the Timed Up and Go test between before treatment (V1), after 6-week of treatment (V13) and follow up at 12 weeks (V14);Change scores in the Schwab & England ADL score between before treatment (V1), after 6-week of treatment (V13) and follow up at 12 weeks (V14);Change scores in the Parkinson's Disease Questionnaire (PDQ-39) between before treatment (V1), after 6-week of treatment (V13) and follow up at 12 weeks (V14);Change doses of levodopa agent consumption before treatment (V1), after 6-week of treatment (V13) and follow up at 12 weeks (V14);Change scores in the EuroQol(EQ-5D)-5D-5L between before treatment (V1), after 6-week of treatment (V13) and follow up at 12 weeks (V14);A sub-group analysis of the change of total Movement disorder society-unified Parkinson's disease rating scale (MDS-UPDRS) score between the Cold syndrome and Hot syndrome patients according to the results of the Cold-Hot syndrome questionnaire between before treatment (V1) and after 6-week of treatment (V13);Clinical effectiveness assessment based on the modified Hoehn & Yahr stage;Safety assessment;Cost-effectiveness analysis;Change score of Movement disorder society-unified Parkinson's disease rating scale (MDS-UPDRS) part ?score between before treatment (V1) and after 6-week of treatment (V13);Change score of Movement disorder society-unified Parkinson's disease rating scale (MDS-UPDRS) part ? score between before treatment (V1) and after 6-week of treatment (V13);Change score of Movement disorder society-unified Parkinson's disease rating scale (MDS-UPDRS) part ? score between before treatment (V1) and after 6-week of treatment (V13);Change score of Movement disorder society-unified Parkinson's disease rating scale (MDS-UPDRS) part ? score between before treatment (V1) and after 6-week of treat | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-Hun Kim
Kyung Hee University Oriental Medical Center
Outcome results
None listed