Examine whether Curcumin can be effective in prevention, improving diabetes and its complications?
Design
Controlled clinical trial, community-based and pragmatic, with parallel, blind, and non-randomized groups.
A statistical population of 120 patients with diabetic neuropathy.
Patients are divided into two groups A and B. Group A consists of 60 patients as cases and group B 60 patients with diabetes as the control group. In a 3-month interval, group A receives 1 capsule of sinacurcumin every day. This is while group B patients receive placebo at similar intervals. At the end of the 3-month period, a laboratory profile similar to the beginning of the course are created for each patient. The results are examined, analyzed and compared
Settings and conduct
Mashhad University of Medical Sciences;
Two-sided blinding (patients and researchers)
Participants/Inclusion and exclusion criteria
Entry requirements :
Diabetes mellitus patients with neuropathy (gloves and socks)
Age range of 70-18 years, sex and have at least five years of illness.
The same type of medication used,Taking oral medicine and Controls for Diabetes.
Intervention groups
Intervention group: curcumin
control group: placebo
Main outcome variables
1. HbA1C level
2. lab profile includes Lip a, BUN, U/A,Cr,FBS,TG,TC,HDL,LDL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130811014330N6
Registration date:2019-06-02, 1398/03/12
Registration timing:retrospective
Last update:2019-06-02, 1398/03/12
Update count:0
Registration date
2019-06-02, 1398/03/12
Registrant information
Name
Hamid Reza Rahimi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1800 2288
Email address
rahimihr891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences,vice chancellor for research
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin on neurological complications of diabetes and HbA1c levels
Public title
The effect of curcumin on neurological complications of diabetes and HbA1c levels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes mellitus with neuropathy (gloves and socks)
Age range of 70-18 years,
at least five years with illness
The same type of medication used,
Taking oral medicine
Exclusion criteria:
Age over 70 years and under 18 years
Taking insulin
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
First, all patients with type 2 diabetes in 2 medical diagnostic laboratories in the city of Mashhad are examined. 120 patients who are diagnosed with diabetic neuropathy are selected. Patients are divided into two groups of 60 people. The first group is the case and the second group is the control. The first group is given a nano-curcumin capsule and second group, placebo capsules. During the course of the project, both groups are unaware of the type of capsule. Researchers are not aware of the type of capsule during the execution of the project. The appearance and taste of the main drug and the placebo are quite similar and are coded in a special way.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2018-06-27, 1397/04/06
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.091
Health conditions studied
1
Description of health condition studied
diabetic individuals with neuropathic disorders
ICD-10 code
E11.4
ICD-10 code description
Type 2 diabetes mellitus with neurological complications
Primary outcomes
1
Description
HbA1c
Timepoint
before and after using curcumin
Method of measurement
electrophoresis
Secondary outcomes
1
Description
2. The lab profile includes Lip a, BUN, U / A, Cr, FBS, TG, TC, HDL, LDL
Timepoint
Before and after using curcumin
Method of measurement
Spectrophotometry using an autoanalyzer
Intervention groups
1
Description
"Intervention :"This group receives 1 capsule of sinacurcumin every day.at the end of the 3-month period, a laboratory profile similar to the beginning of the course are created for each patient. The results are examined, analyzed and compared.
Category
Treatment - Drugs
2
Description
Control group: patients receive placebo at similar intervals.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Hamid Reza Rahimi
Street address
Imam Reza hospital Sq, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences,vice chancellor for research
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Quraish bilding of MUMS, daneshghah St, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3854 3031
Email
p.relations@mums.ac.ir
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 Sciences,vice chancellor for research
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
Mashhad university of medical sciences
Full name of responsible person
Hamidreza Rahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3800 2301
Fax
Email
rahimihr@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hamidreza Rahimi & Dr.Zahra Mazlum khorasani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinologist and Metabolism Specialist
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3800 2301
Fax
Email
rahimihr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Rahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 1800 2288
Fax
+98 51 1800 2287
Email
rahimihr891@mums.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
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
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
Study data will be published in the form of a scientific paper upon completion of the project.
When the data will become available and for how long
Access to data and results is coincident with the publication of scientific articles in prestigious journals.
To whom data/document is available
Individual access is determined in accordance with the authorizations allowed by the publisher of the article.
Under which criteria data/document could be used
For this, researchers must contact the co-responding author of the article.
From where data/document is obtainable
co-responding author of the article.
What processes are involved for a request to access data/document
Communicate with the co-responding author of the article through the communication channels announced.