Evaluation of the therapeutic effects of saffron (Crocus sativus) on clinical and electrodiagnostic symptoms of patients with type 2 diabetes: a double-blind clinical trial
Evaluation of the therapeutic effects of saffron (Crocus sativus) on clinical and electrodiagnostic symptoms of patients with type 2 diabetes: a double-blind clinical trial
Design
This phase 3study is a placebo-controlled, double-blind, randomized controlled trial will be performed on 60 individuals with type 2 diabetes. Block randomization will be used
Settings and conduct
This study will be performed in Imam Reza Hospital of Tabriz University of Medical Sciences. A demographic information questionnaire will be used. intervention will be given to participants at each visit to be taken every 12 hours. In addition to taking these capsules, people will not stop taking diabetes medications. Also, all variables of this study will be evaluated at the beginning and end of the 3-month period.
According to the double-blind nature of this study, a person who has no role in the intervention performs randomization and assigns patients to intervention or placebo groups based on the random sequence . Another person who is unaware of patient allocation proscribes drugs according to codes. This randomization and assignment of codes will be remained hidden from researchers and participants until the statistical analysis is completed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age more than 18 years
Recent diagnosis (maximum 3 months) of type 2 diabetes
Willingness to participate in the study
Exclusion criteria:
Having type 1 diabetes
Gestational diabetes or other specific types of diabetes
Insulin therapy over the past three months
Intervention groups
The saffron group will receive 100 mg of saffron daily for 3 months, and the placebo group will receive 2 placebo capsules daily for 3 months.
Main outcome variables
clinical and electrodiagnostic of neuropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003217N13
Registration date:2020-12-04, 1399/09/14
Registration timing:prospective
Last update:2020-12-04, 1399/09/14
Update count:0
Registration date
2020-12-04, 1399/09/14
Registrant information
Name
Fariba Eslamian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3967
Email address
eslamiyanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effects of saffron (Crocus sativus) on clinical and electrodiagnostic symptoms of patients with type 2 diabetes: a double-blind clinical trial
Public title
Evaluation of the therapeutic effects of saffron on clinical and electrodiagnostic symptoms of patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes
Symptoms of sensory neuropathy such as numbless, burning and pain, muscle weakness, atrophy and balance disorders
Age more than 18 years
Body mass index (BMI) 18.5–35 kg / m
Recent diagnosis (maximum 3 months) of type 2 diabetes
Willingness to participate in the study
Exclusion criteria:
Having type 1 diabetes
Gestational diabetes or other specific types of diabetes
Insulin therapy over the past three months
Having serious gastrointestinal (GI) diseases including peptic ulcers and gastrointestinal bleeding
Having an autoimmune disease
Osteoarthritis (due to masking the symptoms of neuropathy)
Having a history of inherited neuropathy
Chronic uremia
Allergy to saffron
Use of drugs that affect on the symptoms of neuropathy such as antidepressants and anticonvulsants
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will performed using random blocking with block sizes 10 and 1: 1 assignment ratio using Random allocation software (RAS) software
Blinding (investigator's opinion)
Double blinded
Blinding description
According to the double-blind nature of this study, a person who has no role in the intervention performs randomization and assigns patients to intervention or placebo groups based on the random sequence . Another person who is unaware of patient allocation proscribes drugs according to codes. This randomization and assignment of codes will remain hidden from researchers and participants until the statistical analysis is completed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St. / Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2020-10-26, 1399/08/05
Ethics committee reference number
IR.TBZMED.REC.1399.734
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E08.40
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Reduction on the risk of clinical symptoms of neuropathy
Timepoint
before intervention and 3 months after intervention
Method of measurement
Michigan Questionnaire
2
Description
Changes in electrodiagnostic of neuropathy
Timepoint
before intervention and 3 months after intervention
Method of measurement
Electromyography
Secondary outcomes
1
Description
Changes in laboratory parameters associated with type 2 diabetes
Timepoint
before intervention and 3 months after intervention
Method of measurement
Calorimetric enzymatic
Intervention groups
1
Description
Intervention group: Treatment group will receive daily two capsules containing aqueous extract of saffron (50 mg) orally which will be prepared in the geriatrics center for 3 months .
Category
Treatment - Drugs
2
Description
Control group: Placebo group will receive daily two capsules containing cornstarch flours orally which will be prepared in the geriatrics center for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza Hospital
Full name of responsible person
Fariba Eslamiyan
Street address
Imam Reza Hospital, The end of Golgasht St, Daneshgah St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 3967
Email
eslamiyanf@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr Mohammad Samiei
Street address
The end of Golgasht St, Daneshgah St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Eslamiyan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital, The end of Golgasht St, Daneshgah St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 3967
Email
eslamiyanf@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Eslamiyan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital, The end of Golgasht St, Daneshgah St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 3967
Email
Eslamiyanf@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arezou Aminzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital, The end of Golgasht St, Daneshgah St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 3967
Email
afshin.shiva@gmail.com
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
starting in March 2022
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
For Meta-analysis only
From where data/document is obtainable
دکتر فریبا اسلامیان: Eslamiyanf@tbzmed.ac.ir
What processes are involved for a request to access data/document
Will be done for documented and registered requests