Effect of supplementary oral L-tyrosin plus 5-hydroxytriptophan on severity of Parkinson's Disease; a clinical trial
The effect of supplementary oral L-tyrosin plus 5-hydroxytriptophan and other essential elements (Dr Daniel capsule) on severity of Parkinson's Disease, quality of life and severity of depression in patients with Parkinson's Disease
Daniel F Fouladi
153 participants
Dec 31, 2013
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- Patients with Parkinson's Disease of grades 1-3 according to Hoehn and Yahr staging system
Exclusion Criteria6
- 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.
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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 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.
Locations(1)
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ACTRN12613001276741