The effect of consumption of hydro-alcoholic extract of Eryngium Billardieri with aerobic exercise on blood level and lipid profile in type 2 diabetic patients
The effect of Eryngium Billardieri herb consumption and aerobic exercise on blood glucose and lipid profile in type 2 diabetes patients
Design
A clinical trial with a control group, with two intervention groups, not blinded, randomized, phase 2 on 45 patients. The Rand function of Excel software will be used for randomization.
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
Inclusion criteria: Age range 35 to 60 years, Suffering from type 2 diabetes, Having fasting blood sugar between 150 and 200 mg/dL, Using metformin and sulfonylurea drugs to control blood sugar, Following the diet given by a nutritionist; Exit criteria: Use of medicinal plants other than Eryngium Billardieri during the research
Intervention groups
The intervening variables of the research include the hydroalcoholic extract of the borage plant (as a capsule) and aerobic exercise. The application of the intervention variables in the groups is as follows: experimental group 1: the effect of Eryngium Billardieri plant + aerobic exercise, experimental group 2: the effect of aerobic exercise, and the control group: no use of Eryngium Billardieri and exercises. The duration of the intervention is six weeks.
Main outcome variables
Blood sugar variables and lipid profile will be taken and calculated on two occasions, before and after the end of the study in the laboratory through blood sampling.
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20211116053081N2
Registration date:2022-10-16, 1401/07/24
Registration timing:prospective
Last update:2022-10-16, 1401/07/24
Update count:0
Registration date
2022-10-16, 1401/07/24
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
2022-10-23, 1401/08/01
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of consumption of hydro-alcoholic extract of Eryngium Billardieri with aerobic exercise on blood level and lipid profile in type 2 diabetic patients
Public title
The effect of Eryngium Billardieri plant and aerobic exercise in diabetes
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
Among the available patients (patients referred to Mohammadzadeh Clinic located in Qazvin city), 45 subjects will be selected and will be randomly assigned to two intervention groups and one control group through the rand function of Excel software. The method of using this software is as follows: in cells A2:A46, we enter all the names of 45 participants. Then we copy RAND formula in cells B2:B46: =RAND()
Then we put the following formula in cell C2:C46 to extract a random value from column A:
=INDEX(SAS2:SAS46,RANK(B2,SBS2:SBS46),1)
Fifteen initial names of cell C in the first experimental group, 15 middle names of cell C in the second experimental group, and 15 last names of cell C in the third group (in cell C, the names of cell A are placed randomly for For example, the person who is in cell A10 is now in cell C2).
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
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Ghazvin
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: 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 - Other
3
Description
Control group: Failure to receive eryngium billardieri and aerobic exercise, receiving blood sugar control drugs, metformin and sulfonylurea group drugs (Glybanglamid-Glyclazide, etc.)