Parkinson'
Conditions
Interventions
Daily oral administration of enteral nutrition formula (Racol NF) 400ml for 12 weeks consecutively.
Sponsors
St. Mariannna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 35 years old and above and less than 80 years old at the time of informed consent. 2. Patients who have lost a weight 5% and above unintentionally within past 6 to 12 months. 3. Patients who are capable of consent and have given voluntary written informed consent. 4. Patients who have benefit of L-DOPA drug at the start of administration. 5. Patients who have administrated L-DOPA and DCA combination drugs more than 6 months consecutively. 6. Patients with stable dosage and administration of antiparkingon's disease drugs before 2 weeks of observation period. 7. Patients who are able to follow the study schedule.
Exclusion criteria
Exclusion criteria: 1. Patients with parkinsonian syndrome 2. Patients have participated in the other studies or clinical trials of enteral nutrition formula. 3. Patients who have received surgical treatment such as stereotactic neurosurgery within 6 months. 4. Patients with psychological symptom such as severe confusion, hallucination, delusion and abnormal behavior. 5. Patients with cognitive dysfunction (MMSE score is no more than 21) 6. Patients with a history of drug allergy (Including any ingredient of study drug) 7. Patients who have administrated other study drugs and drug of post-marketing clinical trial within 3 months before observation period and have not completed other studies at the time of informed consent 8. Patients judged to be inappropriate for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight reduction rate ,amount of PD clinical evaluation scale score change (Total score by each part of UPDRS ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change rate of albumin, prealbumin, acyl-ghrelin, desacyle-ghrelin, leptin | — |
Countries
Japan
Contacts
Public ContactMakoto Shiraishi
St. Mariannna University School of Medicine Neurology
Outcome results
None listed