Diabetes is one of the major metabolic disorders. The aim of this study was to evaluate the effect of saffron and crocin as agents with antioxidant properties for the treatment diabetes mellitus. This project can help to introduce crocin as an anti-diabetic drug. The methods used in this study include: 1. Extraction of saffron with water-alcohol extraction method, 2. Crystallization, 3- Producing tablets of crocin with direct-press. The number of patients is 180 who are divided into 3 groups: group 1 includes 60 type 2 diabetic patients that receive 15 mg/day crocin. Group 2 is 60 patients with type 2 diabetes mellitus that receive saffron with dose 15 mg per day. And group 3 includs 60 type 2 diabetic patients who use placebo. Patients will be enrolled after obtaining informed consent. Patients in 3 groups are under the supervision of an endocrinologist for 3 months. Once before and after the intervention, the clinical tests including fasting blood sugar will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101713058N3
Registration date:2015-12-27, 1394/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-27, 1394/10/06
Registrant information
Name
Seyed Ahmad Mohajeri
Name of organization / entity
Pharmaceutical Research Center, School Of Pharmacy, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
mohajeria@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2017-02-17, 1395/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of crocin and saffron on glycemic control in type 2 diabetic patients; a double blind placebo controlled randomized clinical trial.
Public title
Effects of crocin and saffron on type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Adult patients (18 ≤) with type 1 and 2 diabetes؛ Patients with uncontrolled type 2 diabetes mellitus, and HbA1c> 7-7.5؛ Patients who have the ability to understand overview of the study, treatment and possible side effects؛Filling the consent form. Exclusion criteria: Patients suffering from CKD, and Liver disease, and patients with pregnancy and breast-feeding؛Incidence of any side effects in which the patient cannot continue to study.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad university of Medical science
Street address
Deputy of Science and Technology, Mashhad University of Medical Sciences, next to the Hoveizeh cinema, Daneshgah Avenue
City
Mashhad
Postal code
Approval date
2015-02-24, 1393/12/05
Ethics committee reference number
931153
Health conditions studied
1
Description of health condition studied
Diabetic type 2
ICD-10 code
E10,E14
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Sugar
Timepoint
every week
Method of measurement
glucometer
Secondary outcomes
1
Description
HbA1C
Timepoint
Before intervention,and three months later
Method of measurement
Blood test
Intervention groups
1
Description
control group: Placebo tablet.
Category
Treatment - Drugs
2
Description
Intervention: Group1: Patients With 15 mg per Day Of saffron. Group 2: Patients With 15 mg per Day Of Crocin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital of Mashhad
Full name of responsible person
Dr.Shokofeh Bonakdaran
Street address
Taghi Abad Square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Dr.Seyed Ahmad Mohajeri
Street address
Between shahis Javan and Shahid Al-Shahidi,Shahid Fakori Blvd., Mashhad.
City
Mashahad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Seyed Ahmad Mohajeri
Position
PhD in Pharmacology, Faculty Member of Pharmacodynamy and Toxicology, School of Pharmacy and Targete
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad
City
Mashhad
Postal code
Phone
+98 51 3882 3255
Fax
Email
MohajeriA@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences, School of Pharmacy
Full name of responsible person
Dr. Seyed Ahmad Mohajeri
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad
City
Mashhad
Postal code
Phone
+98 35 1882 3255
Fax
Email
MohajeriA@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Targeted Drug Delivery Research Center, School of Pharmacy, Mashhad University of Medical Sciences,
Full name of responsible person
Samaneh Sepahi
Position
PhD By Research Student
Other areas of specialty/work
Street address
BuAli Research Institute, BuAli Square, Mashhad -Iran, and Mashhad University of Medical Science-Pharmacy School Mashhad
City
Mashhad
Postal code
Phone
+98 35 1882 3255
Fax
Email
sepahis931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)