A study comparing the effectiveness of pomegranate versus Gabapentin for treatment of Diabetic nephropathy in patients of diabetes melitus type 2
Design
This study is clinical trial and double blind. A total of 74 patients with diabetes type 2 will be enrolled in Amiralmomenin hospital in Arak. We will divide patients in 2 groups by simple randomization. Groups are parallel.
Settings and conduct
This study is clinical trial and double blind.A total of 74 patients with diabetes type 2 will be enrolled in Amiralmomenin hospital in Arak. Outcome assessor and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with type 2 diabetes who have painful lower extremity nephropathy for at least 3 months, age between 70 and 30 years, do not take pomegranate pills, do not have severe physical, neurological or psychiatric illness, do not become pregnant or breast-feeding,
Exclusion criteria:Severe sensitivity to pomegranate pills, severe grade 4 heart failure or unstable angina, HbA1c greater than or equal to 8.5
Intervention groups
In the pomegranate medicine group, patients are given pomegranate tablet (225 milligram - Amin.Co Iran)half pills every 12 hours for 3 months. Patients in Gabapentin group were also given a 300 milligram tablet every 8 hours for 3 months.
Main outcome variables
Lower extremity nephropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N137
Registration date:2020-03-15, 1398/12/25
Registration timing:retrospective
Last update:2020-03-15, 1398/12/25
Update count:0
Registration date
2020-03-15, 1398/12/25
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-08-01, 1392/05/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study comparing the effectiveness of pomegranate versus Gabapentin for treatment of Diabetic nephropathy in patients of diabetus melitus type 2
Public title
A study comparing the effectiveness of pomegranate versus Gabapentin for treatment of Diabetic nephropathy in patients of diabetus melitus type
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes who have painful lower extremity nephropathy for at least 3 months
Age between 70 and 30 years
Do not take pomegranate pills.
Do not have severe physical, neurological or psychiatric illness.
Do not become pregnant or breast-feeding.
Exclusion criteria:
Severe sensitivity to pomegranate pills
Severe grade 4 heart failure or unstable angina
HbA1c greater than or equal to 8.5
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two groups A and B.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre , Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2013-07-31, 1392/05/09
Ethics committee reference number
92-150-4
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Lower extremity nephropathy
Timepoint
Start and 3 months after intervention
Method of measurement
Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the pomegranate medicine group, patients are given pomegranate tablet (225 milligram - Amin.Co Iran)half pills every 12 hours for 3 months.
Category
Treatment - Drugs
2
Description
Intervention group: Patients in Gabapentin group were also given a 300 milligram tablet every 8 hours for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Javad Tabaeyan
Street address
Sardasht, Basij squre,Amiralmomenin hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
tabaeean@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?