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Double-blind clinical study of the therapeutic effects of pomegranate juice powder on renal damage in diabetic nephropathy.

Protocol summary

Summary
This study is a double-blind, parallel clinical trial on 40 patients 20 to 75 years of age taking dietary advice and medicine that reduce blood sugar. Patient's urine microalbumin and the amount of protein in urine 24 hours higher than normal and receive a fixed dose of either or both ACEI or ARB at least 3 months. Patients with underlying diseases such as cancer, as well as being on dialysis excluded. At baseline Fasting Blood Sugar, Serum BUN, Serum Cr, Triglycerides, Total Cholesterol, LDL- cholesterol, HDL- cholesterol, ALT, AST , Urine microalbumin and Urine proteine 24houres will be recorded for subjects. In addition to their previous therapy, subjects will receive 120 placebo capsules or capsule containing pomegranate juice powder for a month. Volunteers will be visited monthly and if there is no problem they will receive it again for a months. At the end of 2 months testing and initial evaluation will be repeated and changes will be investigated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121725574N1
Registration date: 2016-05-31, 1395/03/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-31, 1395/03/11
Registrant information
Name
Elnaz Faridi
Name of organization / entity
Motahhari Clinic
Country
Iran (Islamic Republic of)
Phone
+98 71 3227 0295
Email address
faridie@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-02-29, 1394/12/10
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double-blind clinical study of the therapeutic effects of pomegranate juice powder on renal damage in diabetic nephropathy.
Public title
The effect of pomegranate juice powder on diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients 20 to 75 years old receiving reducer blood glucose drug and dietary recommendations for at least 6 month with type II diabetes. That the urine microalbumin and the amount of protein in urine 24 hours higher than normal and receive a fixed dose of either or both ACEI or ARB at least 3 months. Exclusion criteria: certain underlying diseases such as autoimmune diseases or cancer, allergies to plants used in the clinical trial, pregnancy and breastfeeding, dialysis.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Science, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2015-08-01, 1394/05/10
Ethics committee reference number
IR.Sums.REC.1394.132

Health conditions studied

1

Description of health condition studied
Nephropathy caused by diabetes type 2
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus With renal complications Diabetic nephropathy (N08.3*)

Primary outcomes

1

Description
The 24-hour urine protein excretion
Timepoint
Before the intervention, one month after the intervention and after the end of the intervention
Method of measurement
24-hour urine test

2

Description
Urine microalbumin excretion
Timepoint
Before the intervention, one month after the intervention and after the end of the intervention.
Method of measurement
urine test

Secondary outcomes

1

Description
Serum BUN
Timepoint
The beginning and end of the intervention
Method of measurement
blood tests

2

Description
Serum Creatinine
Timepoint
The beginning and end of the intervention
Method of measurement
blood tests

3

Description
Fasting Blood Sugar
Timepoint
The beginning and end of the intervention
Method of measurement
blood tests

4

Description
BMI
Timepoint
The beginning and end of the intervention
Method of measurement
blood tests

5

Description
GFR
Timepoint
The beginning and end of the intervention
Method of measurement
blood tests

6

Description
HDL
Timepoint
The beginning and end of the intervention
Method of measurement
blood tests

7

Description
LDL
Timepoint
The beginning and end of the intervention
Method of measurement
blood tests

8

Description
Cholesterol
Timepoint
The beginning and end of the intervention
Method of measurement
blood tests

9

Description
TG
Timepoint
The beginning and end of the intervention
Method of measurement
blood tests

Intervention groups

1

Description
intervention group:routine treatment+blueberry cap qID,2 months
Category
Treatment - Drugs

2

Description
control group:routine treatment+placebo cap qID,2 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari clinic
Full name of responsible person
Elnaz Faridi
Street address
Motahari Clinic, Namazi Square, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Pouya Faridi
Street address
Shiraz University of Medical Sciences, front of the Felestin street, Zand Avenue, Shiraz.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Pouya Faridi
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Pharmacy, Akbar abad Road, Shiraz.
City
Shiraz
Postal code
Phone
+98 917 314 6562
Fax
Email
faridip@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Roozbeh
Position
Professor
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz.
City
Shiraz
Postal code
Phone
+98 17 3647 3888
Fax
Email
Roozbehj@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Elnaz Faridi
Position
Pharm D Student
Other areas of specialty/work
Street address
School of Pharmacy, Akbar abad Road, Shiraz.
City
Shiraz
Postal code
Phone
+98 71 3227 0295
Fax
Email
elnaz_f11@yahoo.com , faridie@sums.ac.ir
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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