Efficacy and safety of a herbal medication, HH368, for clinical symptoms of idiopathic Parkinson’s disease

Authors
Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2019
INTERVENTION: 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. In the control group, acupuncture treatment and physician consultation will be offered twice a week without herbal medication. In this study, physicians cannot be blinded, but in the case of the outcome assessment, separate assessors other than the physicians will participate in the outcome assessment for blinding. CONDITION: Diseases of the nervous system PRIMARY OUTCOME: 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 OUTCOME: 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) Change doses of levodopa agent consumption before treatment (V1), after 6‐week of treatment (V13) and follow up at 12 weeks (V14) 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 scores in the Berg balance test between 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) 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 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 Timed Up and Go test between before treatment (V1), after 6‐week of treatment (V13) and follow up at 12 weeks (V14) 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) Clinical effectiveness assessment based on the modified Hoehn & Yahr stage Cost‐effectiveness analysis Safety assessment 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
Epistemonikos ID: ae4a5db027954b41ac4241141ff341169782dd73
First added on: Aug 24, 2024