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Assessment of the effect of dill powder on gastrointestinal symptoms, glycemic control, lipid profile, serum levels of oxidant and Inflammatory markers in type 2 diabetic patients

Protocol summary

Study aim
Determination of the effect of dill powder on gastrointestinal symptoms, glycemic control, lipid profile, serum levels of oxidant and Inflammatory markers in type 2 diabetic patients
Design
This is a randomized Double-blinded clinical trial with two parallel groups in Phase 3. In this study 48 patients with type 2 diabetes referring to specialized clinic of Golestan Hospital and Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
This study will be conducted at the specialized clinic of Golestan Hospital in ahvaz.In this study patients would be randomly allocated to the supplement or placebo groups using random number tables. neither the patients nor administrator of the treatment know which capsules are being received. All patients will provide 10 ml fasting venous blood samples at the beginning and at the end of the study.At the beginning and the end of the study gastrointestinal symptoms, fasting glucose, insulin, serum fructosamine, lipid profile, and serum levels of total antioxidant capacity, malondialdehyde and hs- CRP will be detected in all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with type 2 diabetic Body mass index between 25-35 Age between 30-60 years;Exclusion criteria: Having other endocrine disorders, cardiovascular diseases and kidney diseases ,consumption vitamin , herbal, mineral or, antioxidants supplements in the last three months
Intervention groups
women with type 2 diabetes who receive 3 capsules of one gram of dill powder daily for 8 weeks
Main outcome variables
gastrointestinal symptoms, fasting glucose, insulin, serum fructosamine, lipid profile, and serum levels of total antioxidant capacity, malondialdehyde and hs- CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120704010181N12
Registration date: 2018-05-12, 1397/02/22
Registration timing: retrospective

Last update: 2018-05-12, 1397/02/22
Update count: 0
Registration date
2018-05-12, 1397/02/22
Registrant information
Name
Fatemeh Heidari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
haidari-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of dill powder on gastrointestinal symptoms, glycemic control, lipid profile, serum levels of oxidant and Inflammatory markers in type 2 diabetic patients
Public title
The effect of dill powder on the treatment of type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetic Body mass index between 25-35 Age between 30-60 years Desire to collaborate on the research project
Exclusion criteria:
Having other endocrine diseases, cardiovascular, liver, kidney, thyroid Taking steroids or hormone medications, consumption vitamin , herbal, mineral or, antioxidants supplements in the last three months Having physical activity Weight loss diet pregnancy lactation
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple (assigning a person to a particular group completely randomly) using a random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double blind study neither the patients nor researcher the treatment know which capsules are being received. In fact, a third person who knows the contents of the capsules distributes supplements among the participants. The shape, size and color of the capsules are similar in both groups, while their content is different.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Golestan Highway
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-11-20, 1396/08/29
Ethics committee reference number
IR.AJUMS.REC.1396.623

Health conditions studied

1

Description of health condition studied
diabetes
ICD-10 code
,E10-E14
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
fasting Glucose
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
Fasting serum Glucose concentration in mg/dl by kit

2

Description
Serum levels of insulin
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
Fasting serum Insulin concentration in µU/ml by kit

3

Description
Serum Fructosamine
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
Fasting serum Fructosamine concentration in µmol/L by kit

4

Description
Serum cholestrol
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
Fasting Serum cholestrol concentration in mg/dl by kit

5

Description
LDL Cholestrol
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
Fasting Serum HDL Cholestrol concentration in mg/dl, calculating by Friedewald formula

6

Description
HDL Cholestrol
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
Fasting Serum HDL Cholestrol concentration in mg/dl by kit

7

Description
Serum Teriglycerid
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
Fasting serum Teriglycerid concentration in mg/dl by kit

8

Description
hs- CRP
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
serum hs- CRP concentration in mg/L by kit

9

Description
Serum malondialdehyde
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
Fasting serum malondialdehyde concentration in µmol/ml by kit

10

Description
Total Antioxidant Capacity
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
Fasting serum Total Antioxidant Capacity in U/ml by kit

11

Description
Gastrointestinal symptoms
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
Using the questionnaire by percentage

Secondary outcomes

1

Description
Body Mass Index
Timepoint
baseline, 8 weeks after intervention period
Method of measurement
body weight / hight square (kg/m2)

Intervention groups

1

Description
Dill powder, 1 gram , three capsule per day for 8 weeks
Category
Treatment - Other

2

Description
placebo, 1 gram , three capsule per day for 8 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized clinic of Golestan Hospital
Full name of responsible person
Mihammad Ali Sheikhi
Street address
Golestan Highway
City
AHVAZ
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3384 3001
Email
sheikhi-m@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
40
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
Ahvaz University of Medical Sciences
Full name of responsible person
Golnaz Amoohi Foroushani
Position
Master of Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3221 1503
Email
Golnazamoochi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Haidari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8317
Email
haidari-f@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Golnaz Amoochi Foroushani
Position
Master of student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
Golnazamoochi@gmail.com

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
it is not the objective of this study.
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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