Protocol summary

Summary
Objective: Evaluation the effect of ginger on urine protein and urine glucose in type 2 diabetic patients. Design of the study: randomized (six-block method), double-blind study, control with placebo, single arm trial Experimental population: Type 2 diabetic patients which referring to Endocrine clinic of Semnan University of medical sciences. Inclusion Criteria: At least 18 years old; Diabetic patients treated with insulin or glucose lowering drugs Exclusion criteria: Pregnant or lactating women with diabetes; alcoholic; liver disease; symptomatic gallstone; kidney disease; active malignancy; acute infection and warfarin users. Sample size, intervention, intervention time and outcome of study: The sample size of this study is 100 patients which divided into intervention and control groups. Intervention group: 50 patients in the intervention group receiving 1600 mg of ginger (an 800 mg capsule) daily, before lunch and before dinner, for 12 weeks. Control group: 50 patients in the control group receiving daily 1600 mg placebo (an 800 mg capsule containing wheat flour), before lunch and before dinner, for 12 weeks. In this study, Ginger and Placebo capsules are prepared and coded without the knowledge of the prescribers, and after the completion of the study, the capsule code will be provided by the pharmaceutical company to determine which of the patients used Ginger or placebo. Before and after intervention, blood glucose and 24-hour urine protein content are measured in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017103025732N27
Registration date: 2017-11-01, 1396/08/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2017-09-01, 1396/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zingiber on glucose and proteinuria in type2 diabetic patients
Public title
Effect of zingiber on glucose and proteinuria in type2 diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: At least 18 years old; Diabetic patients treated with insulin or glucose lowering drugs Exclusion criteria: Pregnant or lactating women with diabetes; alcoholic; liver disease; symptomatic gallstone; kidney disease; active malignancy; acute infection and warfarin users.
Age
From 18 years old to 70 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
Ethics Committee, Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SEMUMS.REC.1395.207

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
24-hour urine protein
Timepoint
Before and after the intervention
Method of measurement
the experiment

2

Description
Blood sugar
Timepoint
Before and after the intervention
Method of measurement
the experiment

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 50 patients in the intervention group receiving 1600 mg of ginger (an 800 mg capsule) daily, before lunch and before dinner, for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: 50 patients in the control group receiving daily 1600 mg placebo (an 800 mg capsule containing wheat flour), before lunch and before dinner, for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology Clinic, Semnan University of Medical Sciences
Full name of responsible person
Maliheh Yarmohamadi
Street address
17 shahrivar Blvd, Semnan
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Technology, Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Maliheh Yarmohamadi
Position
Nephrologist
Other areas of specialty/work
Street address
Kowsar Hospital, Amin Street, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
Email
are20935@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maliheh Yarmohamadi
Position
Nephrologist
Other areas of specialty/work
Street address
Kowsar Hospital, Amin Street, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
Email
are20935@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maliheh Yarmohamadi
Position
Nephrologist
Other areas of specialty/work
Street address
Kowsar Hospital, Amin Street, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
Email
are20935@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
empty
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