None listed
Conditions
Interventions
Drug : This study has been designed as a randomized, double-blind, and placebo-controlled study.
Once the patients who have voluntarily singed an informed consent form are enrolled in this study, the
Sponsors
Medihelpline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects =30 years old at the time of informed consent 2) Subjects diagnosed with Parkinson’s disease satisfying the UKPDSBB (United Kingdom Parkinson’s Disease Society Brain Bank) Clinical Diagnostic Criteria and showing decreased dopamine transporters in the dopamine transporter imaging (e.g.: ¹8F-FP-CIT PET, etc.) 3) Modified Hoehn and Yahr stage = 3.0 4) K-MMSE (Korean Mini-Mental State Examination) score =20 at the screening visit (visit 1) 5) Subjects who can understand and follow the instructions on this clinical study, and fully participate in the clinical study 6) MDS UPDRS Part ?+Part ? score =18 at baseline (visit 2) 7) Subjects who have voluntarily determined to participate in this study and signed the written informed consent form
Exclusion criteria
Exclusion criteria: 1) Atypical or secondary parkinsonism or benign tremulous parkinsonism 2) History of treatments with levodopa, dopamine agonists, anticholinergics, MAO-B inhibitors, COMT inhibitors, amantadine, or NMDA receptor antagonists (However, subjects who have not been administered such drugs for at least 6 months in a row and have no history of treatment within 4 weeks prior to their written consent can be enrolled) 3) In case the investigators determine the symptom control is difficult with placebo 4) Hypersensitivity to herbal medicine 5) Subjects with dementia whose K-MMSE score is =19, severe psychopathy requiring treatment or hallucination 6) Any disorder that may affect the absorption, distribution, metabolism, and excretion of drugs 7) Clinically significant heart disease 8) Clinically significant hepatic insufficiency (in case of total bilirubin >2.0 mg/dL, or ALT and/or AST >2 times of upper limit of normal) 9) Clinically significant renal insufficiency (serum creatinine =3.0 mg/dL) 10) History of surgical treatment for Parkinson’s disease 11) Glaucoma 12) Malignant tumor 13) Subjects who have been administered another investigational product within 30 days prior to screening 14) Female subjects who are pregnant or lactating, or who have child-bearing potential (i.e., (i) those who are not surgically non-infertile, or (ii) who are not using adequate contraceptive methods [including at least one of the barrier methods], or (iii) who are not sexually abstinent, or (iv) for whom at least 2 years have not elapsed since their last menstruation) 15) History of chronic alcohol or drug abuse within last 6 months 16) Subjects who are otherwise considered to be ineligible for this study on investigators’ judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MDS UPDRS Part ? | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the MDS UPDRS Part ?;Change in the MDS UPDRS Part ?;Change in the MDS UPDRS Part ?+Part ?+Part ?;Change in the Modified Hoehn and Yahr scale;Changes in each and total scores of 9 domains of the K-NMSS;Change in the K-MoCA;Changes in the summary index and total scores of the K-PDQ-39;Change in the K-MADRS;Changes in each and total scores of 8 domains of the K-SCOPA-AUT;Change in the Schwab and England ADL Scale;CGI-I score;Change in the MDS UPDRS Part ? | — |
Countries
Korea, Republic of
Contacts
Public ContactJoong-Seok Kim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed