Effect of Trigonella foenum, Vaccinium arctostaphylos, Cichorium intybus, Matricaria chamomilla and Urtica dioica extract mixture on blood sugar control in type 2 diabetic patients.
The determine of mixture of herbal extracts on blood sugar control in type 2 diabetic patients
Design
Two arm parallel group design of 100 patients, randomized trial with blinded outcome assessment in 2-3 clinical trial phase
Settings and conduct
Patients with type 2 diabetes who have include criteria and referred to a diabetes clinic affiliated to Mashhad University of Medical Sciences will randomly be included in the study and will be placed in two groups of drugs and placebo. The patients and researchers in this study were blinded in
Participants/Inclusion and exclusion criteria
Patients with type 2 diabetes who are being treated with dietary and medication
Intervention groups
To the intervention group, two 500 mg capsules of a mixture of herbal extracts are given daily and two 500 mg capsules of placebo are given daily to the control group.
Main outcome variables
FBS- Lipid profile- HbA1C- S GOT-SGPT- ALP- Creatinine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170821035817N3
Registration date:2019-04-28, 1398/02/08
Registration timing:prospective
Last update:2019-04-28, 1398/02/08
Update count:0
Registration date
2019-04-28, 1398/02/08
Registrant information
Name
Maryam Yaghoubi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2077
Email address
yaghoubim6@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Trigonella foenum, Vaccinium arctostaphylos, Cichorium intybus, Matricaria chamomilla and Urtica dioica extract mixture on blood sugar control in type 2 diabetic patients.
Public title
Effect of Trigonella foenum, Vaccinium arctostaphylos, Cichorium intybus, Matricaria chamomilla and Urtica dioica extract mixture in treatment of diabetes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients treated with Dietary and hypoglycemic agents
Blood HbA1c level 7.5-8.5 %
Fasting blood glucose levels between 130 to 170 mg/dL
Have diabetes for at least two years
40 to 60 years old
Exclusion criteria:
Patient with renal, hepatic and cardiac failure
Patients with diabetic foot ulcer, gangrene, or any severe illness
Painful diabetic neuropathy and depressed patients
Smokers and alcoholic patients
Patients who tend to change their exercise program or diet
Age
From 40 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the include criteria and using the random sampling software, the subjects are divided into two groups of intervention and control. The drugs and placebo are placed in sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant-Clinical care- Researcher
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Scienses
Street address
No.18, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2019-01-17, 1397/10/27
Ethics committee reference number
IR.MUMS.REC.1397.177
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
Baseline and after 3 months at end of the study
Method of measurement
Blood Test
2
Description
HbA1C
Timepoint
Baseline and after 3 months at end of the study
Method of measurement
Blood Test
Secondary outcomes
1
Description
Cholesterol
Timepoint
Baseline and after 3 months at end of the study
Method of measurement
Blood Test
2
Description
Triglycerid
Timepoint
Baseline and after 3 months at end of the study
Method of measurement
Blood Test
3
Description
low-density lipoprotein
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood low-density lipoprotein level will be determined in laboratory by commercially available
4
Description
High-density lipoprotein
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood High-density lipoprotein level will be determined in laboratory by commercially available kit
5
Description
Aspartate aminotransferase
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood aspartate aminotransferase level will be determined in laboratory by commercially available kit
6
Description
Alanine aminotransferase
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood alanine aminotransferase level will be determined in laboratory by commercially available kit
7
Description
Blood urea nitrogen
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood blood urea nitrogen level will be determined in laboratory by commercially available kit
8
Description
Creatinine
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood creatinine level will be determined in laboratory by commercially available kit
9
Description
Alkalin phosphatase
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood Alkalin phosphatase level will be determined in laboratory by commercially available kit
Intervention groups
1
Description
Intervention group: Patients in this group receive a 500 mg capsule of herbal drug two times a day.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive a 500 mg capsule of placebo two times a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic
Full name of responsible person
Zhila Taherzadeh
Street address
No.18. Daneshgah ST.
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
Taherzadehzh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Reza Hajiaghaee
Street address
Institute of Medicinal Plants, Kavosh Blvd., Supa Blvd., Poleh Kordan
City
Karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
Huseini_fallah@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zhila Taherzadeh
Street address
No.18, Dansshgah ST.
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
Taherzadehzh@mums.ac.ir
Grant name
research/961490/1/3208
Grant code / Reference number
961490
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
50
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
Zhila Taherzadeh
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.18, Daneshgah ST.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
TaherzadehZh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Hasan Fallah Huseini
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Research Complex of Jahad Daneshgahi, Kavosh Boulevard, Supa Boulevard, 55th Kilometer of Tehran-Gazvin Freeway, Karaj, Iran.
City
Karaj
Province
Alborz
Postal code
31375-369
Phone
+98 26 3476 4018
Fax
+98 26 3871 3638
Email
huseini_fallah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Hasan FallahHuseini
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Research Complex of Jahad Daneshgahi, Kavosh Boulevard, Supa Boulevard, 55th Kilometer of Tehran-Gazvin Freeway, Karaj, Iran.
City
Karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4018
Fax
+98 26 3476 4021
Email
huseini_fallah@yahoo.com
Web page address
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
There is no further information
When the data will become available and for how long
Not decided yet
To whom data/document is available
Not decided yet
Under which criteria data/document could be used
Not decided yet
From where data/document is obtainable
Not decided yet
What processes are involved for a request to access data/document