None listed
Conditions
Brief summary
Dopamin is the mainstay in treatment of Parkinson's Disease. L-Dopa containing medications have been long used in these patients. However, there are multiple, major complications associated with these medications. Although the main mechanism is not known, it has been suggested that imbalance between dopamine and serotonin may cause this. In this study, for the first time, we are going to test concomitant use of dopamine and serotonin precursors (tyrosine and 5-HTP, respectively) in these patients.
Interventions
Three groups of patients with Parkinson's Disease of grades 1-3 according to Hoehn and Yahr staging system (51 patients in each group) who have not been or are not on any formulation of levodopa will randomly receive daily oral L-tyrosin 500 or 3000 mg plus other elements including 50 mg (in cases on 500 mg L-tyrosin) or 300 mg (in cases on 3000 mg L-tyrosin) 5-hydroxytriptophan (5-HTP), 500 mg cysteine, 1.5 mg pyrodoxine and 0.05 mg selenium (Dr Daniel capsule) in the intervention groups; or or
Three groups of patients with Parkinson's Disease of grades 1-3 according to Hoehn and Yahr staging system (51 patients in each group) who have not been or are not on any formulation of levodopa will randomly receive daily oral L-tyrosin 500 or 3000 mg plus other elements including 50 mg (in cases on 500 mg L-tyrosin) or 300 mg (in cases on 3000 mg L-tyrosin) 5-hydroxytriptophan (5-HTP), 500 mg cysteine, 1.5 mg pyrodoxine and 0.05 mg selenium (Dr Daniel capsule) in the intervention groups; or oral placebo (glucose) in the control group for 6 consecutive weeks. Exercise and diet profiles will be similar during the study period in all three groups. Adherence interventions will include weekly instruction in forms of oral and written material. Adherence to taking medication will be monitored by drug capsule return weekly.
Sponsors
Daniel F Fouladi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients with Parkinson's Disease of grades 1-3 according to Hoehn and Yahr staging system
Exclusion criteria
Hoehn and Yahr stage greater than 3; Atypical or secondary parkinsonism; Any condition other than Parkinson's Disease affecting gait or balance or complicating its assessment; Subjects who have been or are on any formulation of levodopa; Patients with carcinoids, renal disease, or malabsorption.
Outcome results
None listed