Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001276741
Ethics application status
Not yet submitted
Date submitted
15/11/2013
Date registered
19/11/2013
Date last updated
19/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of supplementary oral L-tyrosin plus 5-hydroxytriptophan on severity of Parkinson's Disease; a clinical trial
Scientific title
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
Secondary ID [1] 283599 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 290522 0
Condition category
Condition code
Neurological 290910 290910 0 0
Parkinson's disease
Alternative and Complementary Medicine 290911 290911 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288288 0
Treatment: Drugs
Comparator / control treatment
All the patients will continue their previous treatment(s) such as those against Parkinson' disease or depression. Patients in the control group will receive oral placebos (capsules identical to those with medication in the intervention groups, containing
only glucose) once daily for 6 consecutive weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 290898 0
Severity of Parkinson's Disease according to Unified Parkinson's Disease Rating Scale
Timepoint [1] 290898 0
baseline, week 6, week 12.
Primary outcome [2] 290899 0
Health status according to PDQ-39 questionnaire.
Timepoint [2] 290899 0
baseline, week 6, week 12.
Primary outcome [3] 290900 0
Gait and balance according to Tinetti test
Timepoint [3] 290900 0
baseline, week 6, week 12.
Secondary outcome [1] 305567 0
Severity of depression according to the Beck Depression Inventory-II
Timepoint [1] 305567 0
baseline, week 6, week 12.
Secondary outcome [2] 305568 0
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.
Timepoint [2] 305568 0
week 6.

Eligibility
Key inclusion criteria
Patients with Parkinson's Disease of grades 1-3 according to Hoehn and Yahr staging system
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers will be used for consecutive attending patients at department of neurology.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The Chi-sqaure or Fisher's Exact test for categorical data; One-way ANOVA with Tukey post hoc analysis or the Kruskal-Wallis test with an appropriate post hoc analysis based on data distribution, and the repeated measures analysis for numerical data.
To detect a difference of UPDRS score at least equal to 10, with a standard deviation equal to 18 (according to previous reports), at a significant level of 5% (a two-sided t-test) with 80% power 51 patients will be needed in each group (total=153).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
153
Accrual to date
Final
Recruitment outside Australia
Country [1] 5627 0
Iran, Islamic Republic Of
State/province [1] 5627 0
East Azerbaijan

Funding & Sponsors
Funding source category [1] 288280 0
University
Name [1] 288280 0
Tabriz University of Medical Sciences, Drug Applied Research Center
Country [1] 288280 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Daniel F Fouladi
Address
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building, Daneshgah St., Tabriz-Iran. Post Code: 51656-65811.
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 286998 0
None
Name [1] 286998 0
Address [1] 286998 0
Country [1] 286998 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290175 0
Tabriz University of Medical Sciences
Ethics committee address [1] 290175 0
Tabriz University of Medical Sciences, Daneshgah Square, Daneshgah Street, Tabriz-Iran, Postal Code:51664.
Ethics committee country [1] 290175 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 290175 0
15/12/2013
Approval date [1] 290175 0
Ethics approval number [1] 290175 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44358 0
Dr Daniel F Fouladi
Address 44358 0
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building, Daneshgah St., Tabriz-Iran. Post Code: 51656-65811.
Country 44358 0
Iran, Islamic Republic Of
Phone 44358 0
+989144122542
Fax 44358 0
Email 44358 0
[email protected]
Contact person for public queries
Name 44359 0
Daniel F Fouladi
Address 44359 0
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building, Daneshgah St., Tabriz-Iran. Post Code: 51656-65811.
Country 44359 0
Iran, Islamic Republic Of
Phone 44359 0
+989144122542
Fax 44359 0
Email 44359 0
[email protected]
Contact person for scientific queries
Name 44360 0
Daniel F Fouladi
Address 44360 0
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building, Daneshgah St., Tabriz-Iran. Post Code: 51656-65811.
Country 44360 0
Iran, Islamic Republic Of
Phone 44360 0
+989144122542
Fax 44360 0
Email 44360 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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