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The effect of propolis on glycemic control, Lipid profile, renal function and inflammatory biomarkers in patients with type 2 diabetes mellitus: A randomized double blind clinical Trial.

Protocol summary

Summary
The purpuse of this study is to evaluate the effect of propolis on glycemic control, Lipid profile, renal function and inflammatory biomarkers in patients with type 2 diabetes. In this placebo controlled double blind clinical trial study, 100 volunteer patients with diabetes mellitus that has Hemoglobin A1c (HbA1c) Test between 5.9-8% and Fast blood sugar between 126-200 mg/dl which only use oral hypoglycemic agents and were diagnosed less than 10 years will be randomly selected and divided to control and treatment groups. Patients in treatment group take 2 capsules of propolis daily whereas in control group 2 placebo capsules will given to patients. Level of fast blood sugare, 2 hours postprandial glucose, hemoglubine A1C , high density lipoprotein, low density lipoprotein, Total cholesterol, triglyceride, serum Insulin, blood urea nitrogen, creatinine, uric acid, alkalin phosphatase and liver enzymes, inflammation factors like TNFa, IL10, IL6, hs-CRP and also height and weight will be evaluated in the beginning and in the end of study. Patients will be asked not changing their physical exercises, diet and life style duration of study which take 90 days. In the end effect of propolis on measured factors will be statistically evaluated and reported.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092730008N1
Registration date: 2017-09-07, 1396/06/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-07, 1396/06/16
Registrant information
Name
Maryam Jenabi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3161
Email address
jenabi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of propolis on glycemic control, Lipid profile, renal function and inflammatory biomarkers in patients with type 2 diabetes mellitus: A randomized double blind clinical Trial.
Public title
The effect of propolis in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 25-80 years; Hemoglobin A1c (HbA1c) Test between 5.9-8%; Fast blood sugar between 126-200 mg/dl; patients were diagnosed less than 10 years; patients should only use oral hypoglycemic agents Exclusion criteria: Pregnancy and lactation; Insulin dependent diabetes; sensivity to honey or bee products; Severe renal or hepatitis failure
Age
From 25 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapour University of Medical Scinces
Street address
Golestan
City
Ahvaz
Postal code
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR.AJUMS.REC.1396.430

Health conditions studied

1

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

Primary outcomes

1

Description
Fasting Blood Serum
Timepoint
in the beginning, monthly and in the End of Intervention
Method of measurement
mg/dl with using specific serum kit

2

Description
Body Mass Index (BMI)
Timepoint
in the beginning and in the End of Intervention
Method of measurement
kg/m2 by measuring height and weight and use of scale

3

Description
Blood pressure
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mmHg by using indicator

4

Description
2 hours post prandial glucose
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

5

Description
HbA1C
Timepoint
in the beginning and in the End of Intervention
Method of measurement
% by using specific serum kit

6

Description
Triglyceride
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

7

Description
cholestrol
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

8

Description
High Density Lipoprotein (HDL)
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

9

Description
Low Density Lipoprotein (LDL)
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

10

Description
Very Low Density Lipoprotein (VLDL)
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

11

Description
ALANIN AMINOTRANSFERASE
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

12

Description
ASPATRTATE AMINOTRANSFERASE
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

13

Description
ALKALIN PHOSPHATASE
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

14

Description
BLOOD UREA NITROGEN
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

15

Description
Creatinine
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

16

Description
URIC ACID
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/dl by using specific serum kit

17

Description
Serum Insulin
Timepoint
in the beginning and in the End of Intervention
Method of measurement
IU/ml by using specific serum kit

18

Description
IL6
Timepoint
in the beginning and in the End of Intervention
Method of measurement
Pg/ml by using specific serum kit

19

Description
IL1-B
Timepoint
in the beginning and in the End of Intervention
Method of measurement
Pg/ml by using specific serum kit

20

Description
Tumor Necrosis Factor a
Timepoint
in the beginning and in the End of Intervention
Method of measurement
Pg/ml by using specific serum kit

21

Description
High sensitity C- reactive protein
Timepoint
in the beginning and in the End of Intervention
Method of measurement
ng/ml by using specific serum kit

22

Description
Estimated Glomelural Filtration Rate
Timepoint
in the beginning and in the End of Intervention
Method of measurement
mg/min/1.73m2 by using formula

23

Description
Homestasis model assessment Insulin resistance
Timepoint
in the beginning and in the End of Intervention
Method of measurement
%by using formula

24

Description
Homeostasis model assessment of β-cell function
Timepoint
in the beginning and in the End of Intervention
Method of measurement
%by using formula

Secondary outcomes

1

Description
sensivity
Timepoint
in the begining, monthly and in the end of intervention
Method of measurement
patient complain, physical examination

Intervention groups

1

Description
Propolis, capsule 500mg, oral, twice daily, 3 month
Category
Treatment - Drugs

2

Description
Soya, capsules 500mg, oral, twice daily, 3 month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Treatment Center of Golestan Hospital
Full name of responsible person
Dr. Mehrnoosh Zakerkish, Endocrine Specialist
Street address
Golestan
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
DR. Narges Zaeemzadeh
Street address
Pharmacology Department, Diabetes center, Ahvaz Jundishapour University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Maryam Jenabi
Position
Phd candidate of Pharmacology
Other areas of specialty/work
Street address
Diabetes Center, Ahvaz Jundishapour University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 916 634 4139
Fax
Email
jenabi_maryam@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Pharmacy, Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Jenabi
Position
pharm D, Phd candidate of pharmacology
Other areas of specialty/work
Street address
Diabetes Center, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 91633738380
Fax
Email
jenabi_maryam@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Maryam Jenabi
Position
Pharm D, Phd candidate of pharmacology
Other areas of specialty/work
Street address
Diabetes Center, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
15794 - 61357
Phone
+98 613332368
Fax
Email
jenabi_maryam@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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