Efficacy and safety of a herbal medication, HH368, for clinical symptoms of idiopathic Parkinson’s disease
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0003444
- Lead Sponsor
- KyungHee University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method