The effect of Curcumex on fasting plasma glucose, HbA1c, Lipid profile, Insulin resistance and Inflammatory biomarkers in patients with type 2 diabetes mellitus: A randomized double blind clinical Trial.
The effect of Curcumex on fasting blood glucose, HbA1c, Lipid profile, Insulin resistance and Inflammatory biomarkers in patients with type 2 diabetes mellitus: A randomized double blind Clinical Trial
Design
Two arm parallel group randomised trial Double blinded
Settings and conduct
A study on diabetes is performed in Ahwaz Golestan Hospital in a randomized, double blind clinical trial, The study compares the effect of Curcumex and placebo in two parallel groups of 30 patients
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Baseline A1c <9%
Fasting blood glucose is between 200-126 mg / dl
Patients only use oral hypoglycemic drugs
Duration of diagnosis of diabetes is less than 10 years
Exclusion criteria:
Pregnancy and lactation
Insulin treatment
Sensitization and allergy to black pepper or other ingredients in combination
Significant renal and hepatic failure
Intervention groups
The intervention group includes people with type 2 diabetes who receive curcumex intervention.
The control group includes people with type 2 diabetes who receive placebo.
Main outcome variables
Fasting plasma glucose, HbA1c, Lipid profile, Insulin resistance and Inflammatory biomarkers in patients with type 2 diabetes mellitus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181028041483N1
Registration date:2019-01-16, 1397/10/26
Registration timing:registered_while_recruiting
Last update:2019-01-16, 1397/10/26
Update count:0
Registration date
2019-01-16, 1397/10/26
Registrant information
Name
Ali Asghar Hemmati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8382
Email address
hemmati-aa@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Curcumex on fasting plasma glucose, HbA1c, Lipid profile, Insulin resistance and Inflammatory biomarkers in patients with type 2 diabetes mellitus: A randomized double blind clinical Trial.
Public title
The effect of Curcumex on Type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Baseline A1c <9%
Fasting blood glucose is between 200-126 mg / dl
Patients only use oral hypoglycemic drugs
Duration of diagnosis of diabetes is less than 10 years
Exclusion criteria:
Pregnancy and lactation
Insulin treatment
Sensitization and allergy to black pepper or other ingredients in combination
Significant renal and hepatic failure
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: block
Unit of randomization : individual
Randomization strata in stratified randomization:HbA1C
Tools used in randomization : sealed envelops
How the random sequence was built: table of random numbers
Whether of not allocation concealment was carried out:Sealed envelopes will be opaque
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, principle investigator, outcome assessor,data and safety monitoring board
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Jundishapur University of Medical Sciences Ahwaz
Street address
Esfand Ave, Farvardin Blvd,Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-10-23, 1397/08/01
Ethics committee reference number
IR.AJUMS.REC.1397.522
Health conditions studied
1
Description of health condition studied
diabetes mellitus type 2
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The percentage of people who have fasting blood glucose (200-126 mg / dL)
Timepoint
Before the intervention begins and Day 90
Method of measurement
Parsazmoon's FBS kit
2
Description
The percentage of people who have glycosylated hemoglobin (9% -7%)
Timepoint
Before the intervention begins and Day 90
Method of measurement
Diazyme's HbA1c kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Curcumex 2 times a day for 3 months
Category
Treatment - Drugs
2
Description
Control group: Placebo ,2 times a day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Ali Asghar Hemmati
Street address
Ahvaz ,Farvardin Blvd, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3374 3001
Email
Hemmati_aa@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Asghar Hemmati
Street address
Esfand Ave, Farvardin Blvd,Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61359-39937
Phone
+98 61 3373 8382
Email
Hemmati-aa@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?