Effects of Arctium Lappa root on Serum levels of some biochemical variables in individuals with type 2 diabetes
Design
In this double blind study, a total number of 80 people with type 2 diabetes will be selected.They will be divided into two groups of Arctium Lappa root and control (placebo) by simple randomization method. They will be matched in age and BMI.
Settings and conduct
The purpose of the study and how to do it will be explained to patients and Written consent will be obtained from them to participate in the study.Blood samples are taken from patients at the beginning of the study(Sampling is done in the clinic)and Factors such as blood sugar, fat, etc. are measured in the blood(Invoicing is done in the university laboratory) .Then , the herbal medicine will be used in the participants for 12 weeks, and after this period, blood samples will be taken again and the factors will be measured again in order to evaluate the effect of the medicine. Patients will not be aware of the type of drug and the statistician will not be aware of the type of groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria are:Diagnosis of type 2 diabetes over two years (FBS>125 ، 2hpp>200 , HbA1c>6.5 ),No change in the dose of oral blood glucose lowering medicine during testing,Maintain physical activity and diet as usual during the test,No infection to liver, gastrointestinal and kidney diseases.
Exclusion criteria: People who receive vitamin supplements during the last three months, People treated with insulin and other hormones and People who are pregnant and breastfeeding.
Intervention groups
Recipient group of Arctium Lappa root (One 460 mg capsule per day) and recipient group contains active charcoal with the same dose
Main outcome variables
values of blood sugar, amylase, antioxidants, lipid ratios and insulin resistance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210222050455N1
Registration date:2021-04-22, 1400/02/02
Registration timing:registered_while_recruiting
Last update:2021-04-22, 1400/02/02
Update count:0
Registration date
2021-04-22, 1400/02/02
Registrant information
Name
Masoume Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3638
Email address
m.ghorbani7133@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-04-30, 1400/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Arctium Lappa root on values of blood sugar, amylase, antioxidants, lipid ratios and insulin resistance in individuals with type 2 diabetes
Public title
Effects of Arctium Lappa root in individuals with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of type 2 diabetes over two years (FBS>125 ، 2hpp>200 و HbA1c>6/5 )
No change in the dose of oral blood glucose lowering during testing
Maintain physical activity and diet as usual during the test
No liver, gastrointestinal and kidney diseases
Lack of treatment with anticoagulants
Do not take anti hypertensive drugs and diuretics
No alcohol
No smoking
No allergies
Exclusion criteria:
People who receive vitamin supplements during the last three months
People treated with insulin and other hormones
People who are pregnant and breastfeeding
Age
From 40 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants, healthcare providers and outcome assessors are blinded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, healthcare providers and outcome assessors are blinded.The drug and placebo are packaged in similar packages. The treatment group and placebo group will not be aware of the type of intervention they receive. The statistician will not be informed about the grouping done
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences,Basij square,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-01-24, 1399/11/05
Ethics committee reference number
IR.ARAKMU.REC.1399.309
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Fasting glucose
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
2
Description
Amylase
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Catalase
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
MDA
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Calorimetry
5
Description
Total antioxidant capacity (TAC)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Calorimetry
6
Description
Insulin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Eliza
7
Description
HbA1C
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Calorimetry
8
Description
Lipid profile
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Calorimetry
9
Description
Lipid ratios(Total Cholesterol/HDl-c and LDL-c/HDl-c)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
10
Description
HOMA-B
Timepoint
Before and after 12 weeks of intervention
Method of measurement
HOMA-IR model evaluation
Secondary outcomes
1
Description
Body mass index (BMI)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
weight/height
Intervention groups
1
Description
Intervention group: One capsule Arctium Lappa root (460 mg) per day for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: One capsule placebo charcoal (460 mg) day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Specialized Clinic
Full name of responsible person
Dr. Javad Javaheri
Street address
Seyed Mosque three ways,Imam street
City
Arak
Province
Markazi
Postal code
3134877179
Phone
+98 86 3223 3823
Fax
Email
javaheri_115@yahoo.com
2
Recruitment center
Name of recruitment center
Imam Reza Specialized Clinic
Full name of responsible person
Dr. Javad Javaheri
Street address
After blood transfusion organization,Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
3134877179
Phone
+98 86 3402 0029
Fax
Email
javaheri_115@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3638
Email
Research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Masoume Ghorbani
Position
Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Arak University of Medical Sciences,School of Medicine, , Department of Biochemistry,Basij Square,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3501
Email
M.ghorbani7133@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masoumre Ghorbani
Position
Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Arak University of Medical Sciences,School of Medicine, , Department of Biochemistry,Basij Square,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3501
Email
M.ghorbani7133@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masoume Ghorbani
Position
Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Arak University of Medical Sciences,School of Medicine,Department of Biochemistry, Sardasht, Basij Square, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3501
Email
M.ghorbani7133@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
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
Only results of main outcomes
When the data will become available and for how long
Six months after publishing of the results
To whom data/document is available
Only for academic staffs and universities researches
Under which criteria data/document could be used
Only for international and between universities researches
From where data/document is obtainable
Ali Khosrowbeygi a.khosrowbeygi@arakmu.ac.ir
What processes are involved for a request to access data/document
1. Requesting a team work clinical trial via email. 2. Approving the proposal. 3. Registration of the trial