Effect of supplementary oral L-tyrosin plus 5-hydroxytriptophan on severity of Parkinson's Disease; a clinical trial
Phase 2
- Conditions
- Parkinson's DiseaseNeurological - Parkinson's diseaseAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12613001276741
- Lead Sponsor
- Daniel F Fouladi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 153
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of Parkinson's Disease according to Unified Parkinson's Disease Rating Scale[baseline, week 6, week 12.];Health status according to PDQ-39 questionnaire.[baseline, week 6, week 12.];Gait and balance according to Tinetti test [baseline, week 6, week 12.]
- Secondary Outcome Measures
Name Time Method Severity of depression according to the Beck Depression Inventory-II[baseline, week 6, week 12.];Possible complications of L-tyrosine plus 5-HTP such as problems in appetite, sleep, sexual behavior, temperature and pain sensation, nausea, fatigue, headaches, heartburn, joint pain, mood changes, irritability and changes in heart rate by asking from patients.[week 6.]