Protocol summary

Summary
This study investigated the effect of capsule containing alcoholic extract of Morus Alba leaves on complications of diabetic nephropathy in patients with type II based on a double-blind, parallel clinical trial on 70 patients 35 to 70 years of age receiving dietary advice and hypoglycemia tablets for 3-5 years suffering from diabetic nephropathy. Low density lipoprotein and triglycerides should be less than 130 and 300 respectively. Patients with liver disease and changes in dose excluded. insulin levels, fasting blood glucose, HbA1C, triglycerides, total cholesterol, LDL- cholesterol, HDL- cholesterol, TAC, BUN, Creatinin, pro, ALT , AST ,24 recall receiving food will be recorded for candidates at the beginning of study. Volunteers were randomly divided into two groups according to the table of random numbers and besides their previous treatment will receive 120 capsules containing Morus Alba leaf extract or a placebo capsule which has been prepared by Barij essence pharmaceutical company. In order to blind, drug and placebo were prepared in the same packaging and coded in formulation department of Barij Essence Company. Drug and placebo code will be decoded and analyzed at the end of the study. Volunteers will be visited monthly and preliminary testing and re-done and changes will be examined at the end of second months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016021512438N18
Registration date: 2016-06-08, 1395/03/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-08, 1395/03/19
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Plants
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-04-04, 1396/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial the effect of hydroalcoholicl extracts of Morus Alba leaves capsules on nephropathic complications of diabetic patients type 2
Public title
The effect of capsular extract of Morus Alba leaves on nephropathic complications of diabetes mellitus type 2
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients 35 to 70 years old receiving reducer blood glucose drug and dietary recommendations for 3 to 5 years with type II diabetes. That LDL-cholesterol less than 130 and triglycerides less than 300. Exclusion criteria: liver disease, allergies to plants used in the clinical trial, changing the dose of drug during the study.
Age
From 35 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized based on table of random numbers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
IR.KAUMS.REC.1394.147

Health conditions studied

1

Description of health condition studied
Diabetic Nephropathy
ICD-10 code
E11.2
ICD-10 code description
Non-insulin-dependent diabetes mellitus with renal complications

Primary outcomes

1

Description
Fasting plasma glucose
Timepoint
Baseline and End-of-tria
Method of measurement
blood sample

2

Description
lipid profile
Timepoint
Baseline and End-of-tria
Method of measurement
blood sample

3

Description
insulin
Timepoint
Baseline and End-of-tria
Method of measurement
blood sample

4

Description
Total anti oxidant capacity(TAC)
Timepoint
Baseline and End-of-tria
Method of measurement
blood sample

5

Description
alanine aminotransferase(ALT), Aspartate aminotransferase(AST)
Timepoint
Baseline and End-of-tria
Method of measurement
blood sample

6

Description
Hs-CRP
Timepoint
Baseline and End-of-tria
Method of measurement
blood sample

7

Description
Blood urea nitrogen
Timepoint
Baseline and End-of-tria
Method of measurement
urine sample

8

Description
CREATININ
Timepoint
Baseline and End-of-tria
Method of measurement
urine sample

9

Description
PRO
Timepoint
Baseline and End-of-tria
Method of measurement
urine sample

10

Description
HbA1C
Timepoint
Baseline and End-of-tria
Method of measurement
percent of glycosylated hemoglobin

Secondary outcomes

empty

Intervention groups

1

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

2

Description
intervention group: routine treatment+ extract of Morus Alba leaves cap BID,2 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan diabetes center
Full name of responsible person
Dr Mohsen Taghizadeh
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Science
Full name of responsible person
Dr Gholam Ali Hamidi
Street address
Kashan university of Medical Science, Kashan
City
Kashan
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 Kashan University of Medical Science
Proportion provided by this source
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
Kashan University of Medical Sciences
Full name of responsible person
Dr.Mohsen Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
School of Medicine, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
mohsenta44@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mohsen Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
School of Medicine, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
mohsenta44@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Mahnaz.Mahlouji
Position
Clinical Expert
Other areas of specialty/work
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Postal code
Phone
+98 86 4446 5112
Fax
Email
mahnaz.mahlouji@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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