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Evaluating the Efficacy of Crocin on Movement Disorders and Neuronal Oxidative Stress of Parkinson's Disease; A Double-blind, Randomized, Placebo-controlled Clinical Trial

Protocol summary

Study aim
Investigating the effect of crocin on Parkinson's disease and its clinical symptoms
Design
A clinical trial with the control group, with parallel groups, blinded, randomized, on 54 patients.
Settings and conduct
The patient admission process begins at the Neurology Clinic of Imam Hossein (AS) Hospital and Shahada Tajrish Hospital by examining the level of bradykinesia, cognitive disorders, tremors, and muscle stiffness (Rigidity) of the patients. The patients included in the study are fully aware of the conditions of the trial and their written consent is required to enter the study.
Participants/Inclusion and exclusion criteria
Idiopathic Parkinson's patients, age 30 to 80 years; Idiopathic Parkinson's disease; Not changing the drug regimen, food, and supplements during 8 weeks, who declare their agreement to participate in the clinical trial through a written consent form.
Intervention groups
The intervention group will consume a capsule containing 30 mg of crocin twice a day for 8 weeks. Both groups will receive nutrition education and non-drug solutions for treatment in the form of brochures. The intervention product and placebo will be prepared by Sami Saz Pharmaceutical Company of Mashhad, with the same packaging, shape, taste, and smell.
Main outcome variables
To investigate the use of crocin and its effect on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (episodes of dyskinesia, tremor, and cognitive disorders) in the patient.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170608034390N12
Registration date: 2022-12-09, 1401/09/18
Registration timing: registered_while_recruiting

Last update: 2022-12-09, 1401/09/18
Update count: 0
Registration date
2022-12-09, 1401/09/18
Registrant information
Name
Hadi Esmaily
Name of organization / entity
SBMU
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
esmaily_hadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Efficacy of Crocin on Movement Disorders and Neuronal Oxidative Stress of Parkinson's Disease; A Double-blind, Randomized, Placebo-controlled Clinical Trial
Public title
Evaluating the Efficacy of Crocin on Movement Disorders and Neuronal Oxidative Stress of Parkinson's Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Idiopathic Parkinson's patients Age 30 to 80 years No change in diet, medication and supplements during 8 weeks They declare their agreement to participate in the clinical trial through a written consent form
Exclusion criteria:
Patients with a history of saffron allergy Patients with severe episodes of wearing off Consumers of saffron more than 1 gram per day Taking warfarin, monoamine oxidase inhibitors Pregnant and lactating patients Liver disease Occurrence of urticaria complications; skin itching; Nausea and vomiting and dizziness Patients with severe Hoehn and Yahr stage 5 Parkinson's disease
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
We will randomly divide the participants into two groups with the same size of 27 participants (54 patients in total), to ensure the equal distribution of patients in the two groups, the block randomization method will be used, and 9 blocks of 6 people in total will be created. Sealed Envelope online software will be used to create random codes. Patients who meet the inclusion criteria receive the code in order and based on the grouping of random blocks, for example, the distribution and coding in the first block is as follows, the first patient Group A, the unique code is ZX6, the second patient Group A, the unique code is GA6, Group B third patient, FR9 code, Group B fourth patient, PP3 code, Group A fifth patient, FR9 code, Group B sixth patient, AE8 code. The number of patients in groups A and B in each block is equal, but the random sequence will be different
Blinding (investigator's opinion)
Triple blinded
Blinding description
After preparing the medicine and placebo, they will be packed in the same box by a clinical laboratory expert who is outside the researchers and will be provided with random codes based on the Excel file extracted from the Sealed Envelope software. The package will be transported to the clinic and the codes will closed till the statistical analysis is performed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of
Street address
Valiasr
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2022-06-21, 1401/03/31
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.071

Health conditions studied

1

Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease

Primary outcomes

1

Description
Unified Parkinson's Disease Rating Scale (UPDRS)
Timepoint
At the beginning and eight weeks after the start of the study
Method of measurement
Unified Parkinson's Disease Rating Scale (UPDRS) Questionnaire

Secondary outcomes

1

Description
Malondialdehyde reduction in blood (oxidative stress biomarker)
Timepoint
The beginning of the study and the end of the study
Method of measurement
Spectrophotometry

Intervention groups

1

Description
Intervention group: Patients will take an oral capsule containing 30 mg of crocin in the morning and evening for 8 weeks. Granules containing crocin were obtained from Sami Saz Pharmaceutical Company in Mashhad and filled in capsules in the pharmaceutical pilot production laboratory located in the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences under GMP conditions. The medicine was filled in capsules and in white polyethylene jars was packed in 60 pieces.
Category
Treatment - Drugs

2

Description
Placebos were filled in the pilot production laboratory of the Faculty of Pharmacy, located in the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences, under GMP conditions, in oral capsules with the same color and shape as the study product (intervention group), the capsules were filled and placed in white polyethylene jars. Packed in 60 capsules. Patients will take one in the morning and one in the evening for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital Neurology clinic
Full name of responsible person
Saeed Mohammad Soleymani
Street address
Shahid madani
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@ehmc.ir

2

Recruitment center
Name of recruitment center
Shohadaye Tajrish Educational Hospital
Full name of responsible person
Saeed Mohammad Soleymani
Street address
Shahdari St, Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Pr_shohada@sbmu.ac.ir
Web page address
https://shmc.sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Deputy of Research and Technology, Shahid Beheshti University of Medical Sciences and Health Services, Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi Esmaily
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti School of Pharmacy, Vali Ars AVe
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8887 3704
Fax
+98 21 8887 3704
Email
Esmaily_hadi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi Esmaily
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti School of Pharmacy, Vali Ars AVe
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8887 3704
Fax
+98 21 8887 3704
Email
Esmaily_hadi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi Esmaily
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti School of Pharmacy, Vali Ars AVe
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8887 3704
Fax
+98 21 8887 3704
Email
Esmaily_hadi@sbmu.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
No - There is not 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
potentially the whole data will be published after participants become unidentified
When the data will become available and for how long
The data will be available 6 months after data publish.
To whom data/document is available
Industrial and Academic Researchers
Under which criteria data/document could be used
To carry out further research
From where data/document is obtainable
Dr. Hadi Esmaily, School of Pharmacy, Shahid Beheshti University of Medical Sciences.
What processes are involved for a request to access data/document
It can be provided by sending a request by email. Email to the person in charge of the study: Esmaily_hadi@sbmu.ac.ir
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