Evaluation of Curcumin as add-on therapy in patients with Parkinson's disease
Design
In this clinical trial 60 Patients with Parkinson's disease are allocated based on simple randomization using sealed envelopes. Patients, researcher, outcome assessor and data analyzer are blind to patient allocation to research groups.
Settings and conduct
This study will take place in Ghaem hospital of Mashhad University of Medical Sciences. Patients, researcher, outcome assessor and data analyzer are blind to patient allocation to research groups. The randomly selected sealed envelope is received by an oriented person other than researcher, outcome assessor or data analyzer who give the patients drug or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients who are diagnosed with Parkinson's disease based on MDS clinical diagnostic criteria for Parkinson's disease and at least 30 years of age
2. Patients who are receiving dopaminergic treatment and their symptoms are under control
3. Patients with signed informed consent
Exclusion criteria:
1. Severe systemic or psychologic disease
2. History of Gastrointestinal bleeding
3. Aspirin use over 325mg/day, any anticoagulant or anti-platelet drug use such as heparin or warfarin, antioxidant use except vitamin E up to 2000 IU/day and vitamin C up to 500mg/day
Intervention groups
In this study patients allocated to drug or placebo groups. In drug group patients receiving Curcumin in Nanomicelles form as SinaCurcumin for 9 months with 80mg/day dosage in addition to their dopaminergic treatment. Placebo group receives placebo as same as drug group.
Evaluation of Curcumin as add-on therapy in patients with Parkinson's disease on MDS-UPDRS scale: A Randomized Double-blind Placebo-controlled Trial
Public title
Effectiveness of Curcumin in patients with Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are diagnosed with Parkinson's disease based on MDS clinical diagnostic criteria for Parkinson's disease and at least 30 years of age
Patients who are receiving dopaminergic treatment and their symptoms are under control
Patients with signed informed consent
Exclusion criteria:
Severe systemic or psychologic disease
History of Gastrointestinal bleeding
Aspirin use over 325mg/day, any anticoagulant or anti-platelet drug use such as heparin or warfarin, antioxidant use except vitamin E up to 2000 IU/day and vitamin C up to 500mg/day
Age
From 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study we will use simple randomization and sealed envelopes. Patients are allocated based on selection of envelopes with "drug group" or "placebo group" written inside and are randomly arranged by another person other than researcher or data analyzer. allocation concealment is reached through randomization via sealed envelopes that randomly arranged and selected by third person who is giving drug or placebo to the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, researcher, outcome assessor and data analyzer are blind to patient allocation to research groups. The randomly selected envelope is received by an oriented person other than researcher, outcome assessor or data analyzer who give the patients drug or placebo. Patients, researcher, outcome assessor and data analyzer never get access to the allocation information until the end of study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
beginning of study, 3 months after drug initiation, 6 months after drug initiation, 9 months after drug initiation
Method of measurement
MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating) scale which is a based on standard questionnaire, interview and neurological examination of the patients.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Curcumin in form of nanomicelles (SinaCurcumin) as add-on therapy for 9 months with 80mg/day dosage
Category
Treatment - Drugs
2
Description
Control group: Placebo drug identical to SinaCurcumin is given to patients beside their dopaminergic treatment for 9 months daily
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor of research and technology of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Ghodsi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 9, North Kowsar 3, Valkilabad Blvd., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9178684993
Phone
+98 51 3883 3080
Email
Ghodsihr901@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Shoeibi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
No. 5, Samaneh street 21, Ferdowsi Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91786864993
Phone
+98 51 3763 6928
Email
shoeibia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideza Ghodsi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 9, North Kowsar 3, Vakilabad Blvd., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9178684993
Phone
+98 51 3883 3080
Email
ghodsihr901@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
These files could be available upon request:
Patients' data after removing their identity
Research protocol
Statistical methods used in this study
Informed consent file
Research study report
Codes used for allocating and data analyzing
data categorizing file
When the data will become available and for how long
data availability would begin 3 months after article has been published
To whom data/document is available
Any researcher who needs our data to accomplish his research
Under which criteria data/document could be used
Researcher should use these data only in their related research and mention the reference
From where data/document is obtainable
researchers should send their request to Mr. Hamidreza Ghodsi by email or mail post.
Email: ghodsihr901@mums.ac.ir
Address: Block 9, North Kowsar street 3rd, Mashhad, Iran
What processes are involved for a request to access data/document
Researchers should send their request with information about their goals and protocol of their study and how our data is needed for their results. requests will be responded in 14 working days.