Effect of combination of Chromium, Cinnamon, Urtica, eryngium and D.sophia on glycemic, antioxidant, inflammatory indices, lipid profile and HOMA index in type 2 diabetic patients
Effect of combination of Chrome, Cinnamon, Urtica, eryngium and D.sophia on glycemic, antioxidant, inflammatory indices, lipid profile and Homeostatic Model Assessment (HOMA) index in type 2 diabetic (T2DM) patients
Design
Individuals are divided into 2 groups of 30 intervention and placebo. The intervention group will receive a capsule containing herbal extract powder twice a day, and the placebo group will receive a capsule containing wheat flour, which looks exactly like the capsule of the intervention group, and the duration of the study will be 8 weeks.
Settings and conduct
The subjects will be selected from patients referred to the Endocrinology and Metabolism Clinic of Qazvin University of Medical Sciences. Individuals are divided into 2 groups of 30 intervention and placebo. Because supplements and placebos are similar in shape, participants and researchers are not aware that placebos or supplements are taken in each group. In the data analysis stage, the analyzer does not know the identity of the groups.
Participants/Inclusion and exclusion criteria
Volunteered
Type 2 Diabetes Mellitus (T2DM)
age 30 - 60
No change in treatment and medications in at least the last 2 months
Average level of physical activity
Body mass index between 25 and 30
Hemoglobin-A1C (HbA1C) between 7and 9
Intervention groups
The intervention group will receive 2 mg daily capsules containing herbal extract powder for 2 months and the placebo group will receive capsules containing wheat flour similar to the capsules of the intervention group.
Effect of combination of Chromium, Cinnamon, Urtica, eryngium and D.sophia on glycemic, antioxidant, inflammatory indices, lipid profile and HOMA index in type 2 diabetic patients
Public title
Effect of novel combination of herbal extracts in type 2 diabetic patients indices
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteered
Type 2 Diabetes Mellitus (T2DM)
age 30 - 60
No change in treatment and medications in at least the last 2 months
Average level of physical activity
body mass index between 25 and 30
HA1C between 25 and 30
Exclusion criteria:
Having diabetes for more than ten years
Pregnancy and lactation
Hospitalization during the study
Patients with severe renal and hepatic impairment and any other acute illness
Occurrence of any side effects due to the intervention
Menopause and hormone therapy
Diet change
Changes in the physical activity level
Taking any dietary supplement from 2 months before to the end of the study
History of any allergies
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
patients, researchers and statiscal anlyser
Individuals are divided into 2 groups of 30 intervention and placebo. Because supplements and placebos are similar in shape, participants and researchers are not aware that placebos or supplements are taken in each group. In the data analysis stage, the analyzer does not know the identity of the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
qazvin university of medical sciences
Street address
qazvin university of medical sciences, bahanor blv. qazvin iran
City
qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2020-04-25, 1399/02/06
Ethics committee reference number
IR.QUMS.REC.1399.020
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
2
Description of health condition studied
immune and anti-oxidant system
ICD-10 code
E00–E89
ICD-10 code description
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Primary outcomes
1
Description
Fasting Plasma Glucose (FBS)
Timepoint
Benign of the study and after 8 weeks in the end of the study
Method of measurement
Biochemistry tests
Secondary outcomes
1
Description
Plasma insuline
Timepoint
Benign of the study and after 8 weeks in the end of the study
Method of measurement
Biochemistry tests
Intervention groups
1
Description
Group 1 - Intervention: In this group, patients will receive 100 mg capsules containing herbal extract powder twice a day. The extracts have been purchased and the final combination formulated. Patients will first be interviewed by a trained nutritionist and questionnaires related to the general conditions and anthropometric measurements will be completed.
Category
Treatment - Other
2
Description
Group 2 - Placebo: They will receive a capsule containing wheat flour and very similar to the capsules of the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital - Qazvin
Full name of responsible person
Mohammad Reza Shiri Shahsavar
Street address
Qazvin University of Medical Scienses, Bahonar blv, Qazvin Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9581
Email
nutshiri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Reza Shiri Shahsavar
Street address
Qazvin University of Medical Scienses, Bahonar blv, qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9581
Email
nutshiri@gmail.com
Grant name
Vice Chancellor for Research and Technology of Qazvin University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Reza Shiri Shahsavar
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
qazvin university of medical scienses, Bahonar blv, qazvin
City
qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9581
Email
nutshiri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Reza Shiri Shahsavar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Scienses, Bahonar blv, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9581
Email
nutshiri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Reza Shiri Shahsavar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Scienses, Bahonar blv, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9581
Email
nutshiri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Not applicable
Title and more details about the data/document
The data will be published in the thesis and article
When the data will become available and for how long
At most 6 months
To whom data/document is available
It will be available to everyone, such as individuals, scientific institutes, industry
Under which criteria data/document could be used
Thesis data will be made available to students and researchers to use the results of plant extracts on the study variables if necessary.
From where data/document is obtainable
Published database and valid journals and, By email to the executive and corresponding author: "nutshiri@gmail.com" and cell No. 09143016970, Or refer to the library of Qazvin University of Medical Sciences, Qazvin Bahonar Blvd., Qazvin University of Medical Sciences, telephone number 02833336001 and site address www.qums.ac.ir.
What processes are involved for a request to access data/document
By email to the executive and corresponding author: "nutshiri@gmail.com" and cell No. 09143016970, Or refer to the library of Qazvin University of Medical Sciences, Qazvin Bahonar Blvd., Qazvin University of Medical Sciences, telephone number 02833336001 and site address www.qums.ac.ir.