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Effect of Ginger supplement in Adjunct with Non-surgical periodontal Therapy on Periodontal status, Glycemic Control, lipid profile, Antioxidant status and some inflammatory markers in type 2 Diabetes Patients with Periodontitis

Protocol summary

Summary
The purpose of this study is to investigate the Effect of Ginger supplement in Adjunct with Non-surgical Periodontal Therapy on Periodontal status, Glycemic Control, lipid profile, Antioxidant status and some inflammatory markers in type 2 Diabetes Patients with Periodontitis. In this double-blind, single center clinical trial study, 46 diabetic patients with chronic periodontitis are selected and randomly divided into two intervention (n=23) and control (n=23) groups. Randomization will be done using sealed envelope method. The intervention group will receive four Ginger tablets(500 mg produced by Dineh Company, Iran) for 60 days, equal to 2 grams per day (1g before lunch, 1g before dinner). The control group will receive four 500 mg placebo tablets (containing fiour pease) for 60 days. Non-surgical periodontal therapy will be performed for all patients during this study. Some demographic data including Age, Sex, Anthropometric indices such as: Weight, Height, BMI, Waist and Hip circumferences; Biochemical indices including: Fasting blood glucose, HbA1C, lipid profile, Antioxidant status(MDA , TAC) and some inflammatory markers(TNF-α , HS-CRP) and Periodontal indices (Bleeding index, Pocket depth, Plaque index and Clinical attachment level), Physical activity and 3-days 24-hour recall are evaluated pre and post intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017030432874N1
Registration date: 2017-04-04, 1396/01/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-04, 1396/01/15
Registrant information
Name
Hasan Gholinezhad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61336754360
Email address
gholinezhad.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2017-06-04, 1396/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ginger supplement in Adjunct with Non-surgical periodontal Therapy on Periodontal status, Glycemic Control, lipid profile, Antioxidant status and some inflammatory markers in type 2 Diabetes Patients with Periodontitis
Public title
The effect of Ginger supplementation in the treatment of type 2 Diabetic patients with Periodontitis.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Males and females aged 30 – 60 year; type 2 Diabetic patients who have been suffering from the disease for at least 5 years and have chronic periodontal disease; BMI ≥ 18.5 and < 30kg/m2. Exclusion criteria: Diabetic patients being under insulin therapy; Pregnancy; Breast feeding ; History of Periodontal treatment
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 46
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
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan, Iran
City
Ahvaz
Postal code
61357-15794
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.AJUMS.REC.1395.806

Health conditions studied

1

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

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

2

Description
HbA1C
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

3

Description
LDL.C
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

4

Description
HDL.C
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

5

Description
Triglyceride
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

6

Description
Total cholestrol
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

7

Description
TNF-α
Timepoint
Before and after the intervention
Method of measurement
ELISA

8

Description
hs-CRP
Timepoint
Before and after the intervention
Method of measurement
ELISA

9

Description
MDA
Timepoint
Before and after the intervention
Method of measurement
ELISA

10

Description
TAC
Timepoint
Before and after the intervention
Method of measurement
ELISA

11

Description
Bleeding during probe
Timepoint
Before and after the intervention
Method of measurement
Evaluation of bleeding

12

Description
Plaque index
Timepoint
Before and after the intervention
Method of measurement
Plaque is on the tooth surface

13

Description
Clinical attachment level
Timepoint
Before and after the intervention
Method of measurement
Depth study of cement and enamel plaque periodontal

14

Description
Pocket dept
Timepoint
Before and after the intervention
Method of measurement
The probing depth is measured by the probe.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group receives four 500 mg Ginger tablets per day(1g before lunch, 1g before dinner) for 60 days.
Category
Other

2

Description
The Control group receives four 500 mg placebo tablets (containing fiour pease) per day (1g before lunch, 1g before dinner), for 60 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Golestan Hospital
Full name of responsible person
hasan gholinezhad
Street address
Golestan treatment training center, Golestan street, Ahvaz, Khosetan, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hasan Gholinezhad
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan, Iran
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3333 3477
Fax
Email
hasan.gholinezhad@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Ahmad Zarejavid
Position
Professor of Ahvaz Jundishapur University of Medical Sciences
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan, Iran
City
Ahvaz
Postal code
Phone
+98 87433331257
Fax
Email
00987433331257
Web page address
ahmaddjavid@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hasan Gholinezhad
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan, Iran
City
Ahvaz
Postal code
Phone
00
Fax
Email
hasan.gholinezhad@gmail.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
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