1. Home
  2. Approved trials
  3. » فارسی

Comparison of six weeks of regular aerobic exercises with hydroalcoholic extract of Eryngium billardieri plant with aerobic exercises on fasting blood sugar and betatrophin serum levels in type 2 diabetic patients.

Protocol summary

Study aim
The effect of hydroalcoholic extract of eryngium billardieri plant along with aerobic exercise on fasting blood sugar and betatrophin serum levels in type 2 diabetic patients.
Design
45 eligible subjects will be randomly placed into two experimental groups and one control group through the rand function of Excel software: 1- a group of l extract of eryngium billardieri along with aerobic exercises 2- a group of aerobic exercises 3- control group (not receiving plant Bellows and aerobic exercise). The research design is unblinded, phase 1-2, factorial and therapeutic.
Settings and conduct
Subjects in the hydroalcoholic extract group will take two 100 mg capsules containing hydroalcoholic extract of eryngium billardieri plant in the morning and evening. Aerobic exercises will also be done 5 days a week, 60 minutes a day with moderate intensity. The study is not blinded and will take place in Qazvin city.
Participants/Inclusion and exclusion criteria
Age range 35 to 60, suffering from type 2 diabetes, having fasting blood sugar between 150 and 200 mg/dL, using metformin and sulfonylurea group drugs to control blood sugar. Following the diet given by the nutritionist, not using any medicinal plants other than eryngium billardieri during the research, ability to perform aerobic exercise.
Intervention groups
The present research includes three groups. In experimental group 1, the effect of hydroalcoholic extract of eryngium billardieri plant along with aerobic exercise and in experimental group 2, only the effect of aerobic exercise on dependent variables of blood sugar and betatrophin serum levels will be investigated. In the control group, eryngium billardieri and aerobic exercises will not be used.
Main outcome variables
After applying the intervention variables, blood sugar and betatrophin serum levels will be calculated as before the study through blood sampling in the laboratory.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211116053081N1
Registration date: 2022-09-13, 1401/06/22
Registration timing: prospective

Last update: 2022-09-13, 1401/06/22
Update count: 0
Registration date
2022-09-13, 1401/06/22
Registrant information
Name
Zohreh Eskandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3369 1975
Email address
z.eskandari@raja.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-11-06, 1401/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of six weeks of regular aerobic exercises with hydroalcoholic extract of Eryngium billardieri plant with aerobic exercises on fasting blood sugar and betatrophin serum levels in type 2 diabetic patients.
Public title
The effect of two therapeutic methods of regular aerobic exercise and Eryngium billardieri extract on type 2 diabetes patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 35 to 60 suffering from type 2 diabetes having fasting blood sugar between 150 and 200 mg/dL using metformin and sulfonylurea group drugs (glibenglamid, gliclazide, etc.) to control blood sugar Following the diet given by the nutritionist not using any medicinal plants other than eryngium billardieri during the research
Exclusion criteria:
Having regular physical activity (more than two sessions per week) during the last six months Inability to perform aerobic exercises due to physical diseases such as atherosclerosis, orthopedic problems, etc. Having diseases other than diabetes such as blood pressure, cardiovascular diseases and thyroid diseases
Age
From 35 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the eligible subjects, they will be randomly divided into three groups. To place each subject in one of the three groups, a lottery will be done in Excel in such a way that the names of all qualified people will be entered in a column in Excel, and finally, the RAND and RANDBETWEEN functions will be used to randomly select the subjects in the groups. will be used. Then the subjects will be placed in one of the following groups. 1- The group of taking hydroalcoholic extract of eryngium billardieri along with aerobic exercises. 2- The group of aerobic exercises. 3- The control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ghazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard, Ghazvin
City
Ghazvin
Province
Qazvin
Postal code
5981134197
Approval date
2022-07-06, 1401/04/15
Ethics committee reference number
IR.QUMS.REC.1401.104

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
blood sugar
Timepoint
Beginning and end of the sixth week of study
Method of measurement
Serum blood (ELISA)

2

Description
Betatrophin serum levels
Timepoint
Beginning and end of the sixth week of stud
Method of measurement
By ELISA method using kit ( ZEllBIO GmbH)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Receiving 100 mg capsules of eryngium billardieri twice a day in the morning and in the evening and aerobic exercises for six weeks, 5 days a week, 60 minutes every day with an average intensity of 50% to 75% of the maximum oxygen consumption.
Category
Treatment - Drugs

2

Description
Intervention group 2: Intervention group: aerobic exercises for six weeks, 5 days a week, 60 minutes every day with an average intensity of 50% to 75% of the maximum oxygen consumption.
Category
Treatment - Drugs

3

Description
Control group: Not using eryngium billardieri extract and aerobic exercises
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mohammadzadeh Clinic
Full name of responsible person
Mohammad Reza Shiri Shahsavar
Street address
Mohammadzadeh Clinic, 12 Amirkabir Street, Nakhabgan Blvd., Jhanbazan Square, Qazvin
City
Ghazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 28 3369 9022
Email
Mr.shiri@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Raja University
Full name of responsible person
Ali Yaghoubi
Street address
Raja University, Norouzian st, Ghavin
City
Ghazvin
Province
Qazvin
Postal code
34145-1177
Phone
+98 28 3367 7101
Fax
+98 28 3367 7105
Email
info@raja.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Raja University
Proportion provided by this source
100
Public or private sector
Private
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 of nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Sciences, Nawab Street, Qazvin
City
Ghazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 28 3333 6001
Email
Mr.shiri@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zohreh Eskandari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Qazvin University of Medical Sciences, Nawab Street, Ghazvin
City
Ghazvin
Province
Qazvin
Postal code
3414763803
Phone
+98 28 3369 1975
Email
z.eskandari@raja.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zohreh Eskandari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Qazvin University of Medical Sciences, Nawab Street, Qazvin
City
Ghazvin
Province
Qazvin
Postal code
3414763803
Phone
+98 28 3369 1975
Email
z.eskandari@raja.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I have no justification
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...