Protocol summary

Summary
The purpose of this study is to evaluate the effect of Ribes khorassanicum hydro ethanolic extract supplementation on metabolic parameters of type 2 diabetic patients. The study design is randomized, double blind (both patients and researchers) placebo controlled trial. The study population consists of type 2 diabetes patients (aged 35–60 years) presenting to Diabetes clinic (Emam Reza Hospital, Mashhad University of Medical Sciences). One hundred eligible patients will be chosen and assigned to intervention and placebo groups by random allocation (Permuted block randomization). Patients with 6 months diagnosed diabetes and treated with anti-diabetic drug will be included. Patients with cardiac, renal, hepatic diseases and who had concomitant infections, insulin injection, smoking, pregnancy and breastfeeding, recent (in the last month) and concurrent use of herbal medications, aspirin and anticoagulant drug will be excluded. The patients will be treated with Ribes khorassanicum hydro ethanolic extract (1 capsule=500 mg, every 12 h) or placebo for 3 months. Before and at the end of the study, patients' blood samples will be taken and fasting blood sugar, 2-h post-prandial, glycated hemoglobin, fasting insulin, fasting blood levels of lipids, liver enzymes and creatinine will be measured. Body mass index, diastolic and systolic pressure will be evaluated too.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017030432857N1
Registration date: 2017-04-27, 1396/02/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-04-27, 1396/02/07
Registrant information
Name
Zahra Gholamnezhad
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00985138828565, 00985138002236
Email address
gholamnezhadz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-08-22, 1396/05/31
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ribes khorassanicum hydro ethanolic extract supplementation compared with placebo on metabolic parameters of diabetes in type 2 diabetic patients
Public title
The effect of Ribes khorassanicum in diabetes treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 35-60, with 6 month diagnosed diabetes (FBS≥126 mg/dL, Blood sugar, 2-h post-prandial ≥ 200 mg/dL and HbA1c ≥ 6.5) and used anti-diabetic drug. Exclusion criteria: Patients with cardiac, renal, and hepatic diseases, patients who had concomitant infections, insulin injection, smoking, pregnancy and breast-feeding, patients with recent (in the last month) and concurrent use of herbal medications, aspirin, anticoagulant drug and any report of probable side effect of this study intervention.
Age
From 35 years old to 60 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 of Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Ghoraishy Building, University Street, Mashhad
City
Mashhad
Postal code
Approval date
2017-02-08, 1395/11/20
Ethics committee reference number
IR.MUMS.fm.REC.1395.544

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
FBS
Timepoint
Before intervention, 3 month after intervention
Method of measurement
Enzymatic kit

2

Description
2-h post-prandial
Timepoint
Before intervention, 3 month after intervention
Method of measurement
Enzymatic kit

3

Description
HbA1c
Timepoint
Before intervention, 3 month after intervention
Method of measurement
Enzymatic kit

4

Description
Fasting insulin
Timepoint
Before intervention, 3 month after intervention
Method of measurement
ELISA kit

Secondary outcomes

1

Description
Hepatic Enzymes
Timepoint
Before intervention, 3 month after intervention
Method of measurement
Enzymatic kit

2

Description
Creatinine
Timepoint
Before intervention, 3 month after intervention
Method of measurement
Enzymatic kit

3

Description
Fasting blood levels of lipids
Timepoint
Before intervention, 3 month after intervention
Method of measurement
Enzymatic kit

4

Description
Body mass index
Timepoint
Before intervention, 3 month after intervention
Method of measurement
height (cm), weight (kg), BMI (kg/square meters)

5

Description
Blood pressure
Timepoint
Before intervention, 3 month after intervention
Method of measurement
Sphygmomanometer

Intervention groups

1

Description
Intervention group: patients will be treated with Ribes khorassanicum hydro ethanolic extract (1 capsule = 500 mg, every 12 h) for 3 months.
Category
Treatment - Drugs

2

Description
Placebo group: patients will be treated with placebo (1 capsule = 500 mg, every 12 h) for 3 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Masoud Mohebbi
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice chancellor for research of Mashhad University of Medical Sciences, Ghoraishy Building, University Street, Mashhad
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Gholamnezhad
Position
PhD of physiology, Assistant Professor
Other areas of specialty/work
Street address
Department of Physiology, Faculty of Medicine, Pardis, Azadi Square, Mashhad
City
Mashhad
Postal code
9177948564
Phone
+98 51 3882 8565
Fax
+98 51 3882 8564
Email
gholamnezhadz@mums.ac.ir, gholamnezhadz@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Gholamnezhad
Position
PhD of physiology, Assistant Professor
Other areas of specialty/work
Street address
Department of Physiology, Faculty of Medicine, Pardis, Azadi Square, Mashhad
City
mashhad
Postal code
Phone
+98 51 3882 8565
Fax
Email
gholamnezhadz@mums.ac.ir, gholamnezhadz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Gholamnezhad
Position
PhD of physiology, Assistant Professor
Other areas of specialty/work
Street address
Department of Physiology, Faculty of Medicine, Pardis, Azadi Square, Mashhad
City
Mashhad
Postal code
9177948564
Phone
+98 51 3882 8565
Fax
+98 51 3882 8564
Email
gholamnezhadz@mums.ac.ir, gholamnezhadz@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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