Investigating the effect of curcumin compared to conventional treatment on the severity of diabetic sensorimotor polyneuropathy in patients with type 2 diabetes
Determining the effect of curcumin on the severity of diabetic sensorimotor polyneuropathy and comparing it with routine treatment in patients with diabetic sensorimotor polyneuropathy caused by type 2 diabetes.
Design
A clinical trial with a control group, without blinding, randomized, phase 3, on 40 patients. Block random method is used for randomization.
Settings and conduct
Place of study: Kausar Medical Sciences Clinic, Semnan city; Study population: patients with diabetic sensorimotor polyneuropathy caused by type 2 diabetes
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with diabetic sensorimotor polyneuropathy caused by type 2 diabetes (minimum score of 6 in Tonto Clinical Neuropathy Score); minimum age of 18 and maximum of 70 years.
Exclusion criteria: hypothyroid patients; Patients with cancer of the pancreas, digestive system, kidney, etc.; pregnant patients; Patients who are breastfeeding; Patients who smoke
Intervention groups
Intervention group: In addition to the usual treatment, this group receives 80 mg cocumin capsules daily for two months. Control group: This group only receives the usual drugs.
Main outcome variables
Diabetic sensorimotor polyneuropathy score based on the Toronto Neuropathy Clinical Score system
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230829059301N1
Registration date:2024-03-22, 1403/01/03
Registration timing:registered_while_recruiting
Last update:2024-03-22, 1403/01/03
Update count:0
Registration date
2024-03-22, 1403/01/03
Registrant information
Name
Alireza moslemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4208 6450
Email address
alireza.moslemi91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-19, 1402/12/29
Expected recruitment end date
2024-05-17, 1403/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of curcumin compared to conventional treatment on the severity of diabetic sensorimotor polyneuropathy in patients with type 2 diabetes
Public title
The effect of curcumin on diabetic sensorimotor polyneuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic sensorimotor polyneuropathy caused by type 2 diabetes
A score of at least 6 in Tonto Clinical Neuropathy Score
At least 18 years old and at least 70 years old
Exclusion criteria:
Patients who have sensorimotor polyneuropathy due to other diseases
Patients with hypothyroidism
Those who smoke
Body mass index more than 34.9
Female patients who become pregnant
Being during breastfeeding
Patients who have cancer (such as pancreas, digestive system, kidney, etc.)
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The block permuted randomization method is used to assign people to the intervention and control groups. In this way, first, blocks of size four are formed in each of which there are two people from the intervention group and two people from the control group, which are placed together according to the order of placement. There will be a total of 6 forms of blocks, and each block is assigned a number from one to six, then using a table of random numbers from these six blocks, the blocks are randomly selected one after the other and placed next to each other. They will be placed together until the required sample size is reached. Then, with each of the studied subjects, they will be entered into one of the intervention and control groups according to the determined order.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Central headquarters of Semnan University of Medical Sciences; Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.SEMUMS.REC.1402.188
Health conditions studied
1
Description of health condition studied
Diabetic sensorimotor polyneuropathy
ICD-10 code
G62.8
ICD-10 code description
Other specified polyneuropathies
Primary outcomes
1
Description
Toronto Clinical Neuropathy Score
Timepoint
At the beginning and end of the study
Method of measurement
By medical doctor
2
Description
FASTING BLOOD SUGAR
Timepoint
at the beginning of the study
Method of measurement
BY LABORATORY
3
Description
LDL
Timepoint
at the beginning of the study
Method of measurement
BY LABORATORY
4
Description
blood pressure
Timepoint
at the beginning of the study
Method of measurement
Mercury sphygmomanometer
5
Description
body mass index
Timepoint
at the beginning of the study
Method of measurement
Measuring the ratio of body weight (in kilograms) to the square of height (in meters)Community Verified icon
6
Description
Complete blood count test
Timepoint
at the beginning of the study
Method of measurement
LABORATORY TEST
7
Description
urine analysis
Timepoint
at the beginning of the study
Method of measurement
by the laboratory test
8
Description
Creatinine and blood urea test
Timepoint
at the beginning of the study
Method of measurement
by the laboratory test
9
Description
Blood TSH level test
Timepoint
at the beginning of the study
Method of measurement
by the laboratory test
10
Description
HB1AC
Timepoint
AT THE BEGINNING OF THE STUDY
Method of measurement
BY THE LABORATORY TEST
11
Description
HDL
Timepoint
AT THE BEGINNING OFTHE STUDY
Method of measurement
BY THE LABORATORY TEST
12
Description
TOTAL CHOLESTROL
Timepoint
AT THE BEGINNING OF THE SUDY
Method of measurement
BY THE LABORATORY TEST
13
Description
TG
Timepoint
AT THE BEGINNING OF THE SUDY
Method of measurement
BY THE LABORATORY TEST
14
Description
RANDOM URINE ALBUMIN CERATININE RATIO
Timepoint
AT THE BEGINNING OF THE STUDY
Method of measurement
BY THE LABORATORY TEST
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the usual treatment, this group receives 80 mg cocumin capsules daily for two months.
Category
Treatment - Drugs
2
Description
Control group: This group only receives the usual drugs.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized and subspecialized polyclinic number 1 of Semnan University of Medical Sciences
Full name of responsible person
Mohammad Kermani
Street address
Specialized and subspecialized polyclinic number 1 of Semnan University of Medical Sciences, Golestan town
City
Semnan
Province
Semnan
Postal code
9995135198
Phone
+98 23 3104 3199
Email
clinic@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Central headquarters of Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Alireza Moslemi
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kausar educational research and treatment center, Golestan town
City
Semnan
Province
Semnan
Postal code
99951-35198
Phone
+98 23 3142 0000
Email
alireza.moslemi91@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Frotan
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Kausar educational research and therapeutic center, Golestan Town
City
Semnan
Province
Semnan
Postal code
99951-35198
Phone
+98 23 3142 0000
Email
Dr_frotan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Alireza Moslemi
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kausar educational research and therapeutic center, Golestan Town
City
Semnan
Province
Semnan
Postal code
99951-35198
Phone
+98 23 3142 0000
Email
Alireza.moslemi91@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the main outcome and part of the data can be shared
When the data will become available and for how long
The access period starts 1 month after the results are published
To whom data/document is available
Doctors of my land, Iran
Under which criteria data/document could be used
To treat patients
From where data/document is obtainable
Refer to Abbas.ziari@yahoo.com
Community Verified icon
What processes are involved for a request to access data/document
Send an email and it will be answered within a week