Evaluation of the therapeutic effects of crocin on the reduction of diabetic nephropathy in patients with diabetes mellitus and its comparison with placebo consumption
Design
this study is a prospective, triple-blind, randomized controlled clinical trial, 44 patients will randomly assign to control or intervention group. Crocin 15 mg and placebo tablets will pack in similar bottles and each bottle will have a different code. The nephrologist, student in charge of completing the questionnaires and the patient will not be notified of any grouping. The patients will asked to take their medications once a day for 90 days
Settings and conduct
Yazd Diabetes Research Center
Participants/Inclusion and exclusion criteria
inclusion criteria:
age 18 years or older_A history of type 2 diabetes for at least 5 years, as defined by the WHO in 1985_fasting urine alb/cr ratio of 30 or higher on 2 separate occasions within the past 3 months_HbA1C less than 8_blood pressure less than 160/100_Srcr levels less than or equal to 2 _treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin_treatment of hypercholesterolemia with(but not limited to) a statin
Exclusion criteria:
GFR less than 30_chronic heartfailure with New York Heart Association class III or IV_alcohol dependency or cigarette smoking_use of nsaids and antioxidant supplements within 3 months prior to enrollment in the study_Recent stroke, active cancer, anemia_recurrent urinary tract infection_pregnancy and lactation_Drug intolerance_Serious medical conditions in which the patient is unable to attend regular visits_Mental conditions that prevent conscious consent to enter the study or follow the study protocol
Intervention groups
Intervention group: 15 mg crocin per day and control group: placebo
Main outcome variables
Changes in FBS, HgA1c, BUN, SrCr, 24-h urinary protein, UACR, blood levels of TGF-β
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190810044500N4
Registration date:2020-04-25, 1399/02/06
Registration timing:registered_while_recruiting
Last update:2020-04-25, 1399/02/06
Update count:0
Registration date
2020-04-25, 1399/02/06
Registrant information
Name
Fatemeh Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
f.saghafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effects of Crocin in reducing progression of diabetic nephropathy: A randomized triple-blind placebo-controlled trial
Public title
Evaluation of therapeutic effects of Crocin in reducing progression of diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 18 years or older
A history of type 2 diabetes for at least 5 years, as defined by the WHO
fasting urine albumin/creatinine ratio of 30 mg/g or higher on two separate occasions within the past 3 months
HbA1C less than 8
blood pressure less than 160/100
Serum creatinine levels less than or equal to 2 mg/dL
treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin
treatment of hypercholesterolemia with(but not limited to) a statin
Exclusion criteria:
GFR less than 30 mL/min/1.73 m2
chronic heartfailure with New York Heart Association class III or IV
alcohol dependency or cigarette smoking
use of one of certain specified medications within 3 months prior to enrollment in the study (nonsteroidal anti-inflammatory agents and antioxidant supplements, including vitamin E, vitamin C, fish oil extracts [omega-3 fatty acids], green tea preparations, pomegranate extracts, and grape extracts
Recent stroke, active cancer, anemia
recurrent urinary tract infection
pregnancy and lactation
Drug intolerance
Serious medical conditions in which the patient is unable to attend regular visits include severe cardiovascular disease such as angina or heart attack.
Mental conditions that prevent conscious consent to enter the study or follow the study protocol
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
the patients will be randomly divided into two groups of intervention and control using the permutation blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding will perform on patients, clinical caregivers, including physicians and nurses, as well as variables assessors and data analysts
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
faculty of ethics of medical sciences - shahid sadoughi university of medical sciences
Street address
Gomnam shohada boulevard - shahid sadoughi university of medical sciences
City
yazd
Province
Yazd
Postal code
8915173143
Approval date
2019-04-30, 1398/02/10
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.085
Health conditions studied
1
Description of health condition studied
diabetic nephropathy
ICD-10 code
E11.21
ICD-10 code description
Type 2 diabetes mellitus with diabetic nephropathy
Primary outcomes
1
Description
Fasting blood sugar levels
Timepoint
Before and after intervention
Method of measurement
blood sample
2
Description
glycosylated hemoglobin
Timepoint
Before and after intervention
Method of measurement
blood sample
3
Description
, Blood urea nitrogen (BUN)
Timepoint
Before and after intervention
Method of measurement
blood sample
4
Description
serum creatinine
Timepoint
Before and after intervention
Method of measurement
blood sample
5
Description
24-hour urinary protein
Timepoint
Before and after intervention
Method of measurement
blood sample
6
Description
urinary albumin-creatinine ratio (UACR),
Timepoint
Before and after intervention
Method of measurement
blood sample
7
Description
blood levels of TGF-β
Timepoint
Before and after intervention
Method of measurement
blood sample
Secondary outcomes
1
Description
life quality
Timepoint
Before and after intervention
Method of measurement
questionnaire
2
Description
adverse effects
Timepoint
Before and after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: take a 15 mg crocin tablet made by pouyesh darou sina company once daily for 90 days.
Category
Treatment - Drugs
2
Description
Control group: take a placebo tablet made by pouyesh darou sina company once daily for 90 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
yazd Diabetes Research Center
Full name of responsible person
Behzad Kafami
Street address
Art Hall Alley, Shahid Sadoughi Blvd., Bahonar Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۷۶۹۳۵۷۱
Phone
+98 35 3728 0226
Email
drc@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
مسعود میرزایی
Street address
Bahonar Ave
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3146 2056
Fax
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
behzad kafami
Position
University student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
بلوار شهدای گمنام - دانشگاه علوم پزشکی شهید صدوقی
City
yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3419
Email
behzadk74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Saghafi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Blvd., Yazd Province, Yazd
City
yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Email
F.saghafi@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Saghafi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Blvd., Yazd Province, Yazd
City
yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Email
F.saghafi@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available