This study will be a double blind and cross over clinical trial on 30 patients 10 to 30 years of age, taking insulin with type 1 diabetes for one year. Patients with liver or kidney disease or low levels of lipid profile will be excluded. At the baseline, insulin intake rate, area under the curve of blood glucose at different times in the past week, fasting blood glucose and HbA1C, triglycerides, total cholesterol, LDL- cholesterol, serum HDL cholesterol, CRP and ALT and AST will be recorded for subjects. Besides their previous therapy, subjects will receive 60 placebo or capsules containing morus alba leaf extract for a month prepared by Barij Essence Company. Volunteers will be visited for a month and 2 months wash out .At the end of 1, 3 and 4 months testing and initial evaluation will be repeated and changes will be investigated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030812438N11
Registration date:2015-04-19, 1394/01/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-19, 1394/01/30
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 Essence pharmaceutical company
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydroalcoholic extract of Morus alba on glucose and lipid profiles in patient with diabetes mellitus type 1
Public title
Effect of Morus alba on diabetes mellitus type 1
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients 10 to 30 years who have insulin-dependent diabetes disease and HbA1c in his with more than 7 percent. Exclusion criteria: LDL cholesterol and triglycerides less than 160 and less than 200 respectively. Liver disease, kidney disease, not use of lipid-lowering drugs.
Age
From 10 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Approval date
2015-02-10, 1393/11/21
Ethics committee reference number
29/5/1/5347/پ
Health conditions studied
1
Description of health condition studied
Insulin-dependent diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
HbA1C
Timepoint
months 0,2,4,6
Method of measurement
percent of glycosylated hemoglobin
2
Description
Fasting plasma glucose
Timepoint
months 0,2,4,6
Method of measurement
Enzymatic
3
Description
Tg
Timepoint
months 0,2,4,6
Method of measurement
blood sample
4
Description
cholesterol
Timepoint
months 0,2,4,6
Method of measurement
blood sample
5
Description
LDL
Timepoint
months 0,2,4,6
Method of measurement
blood sample
6
Description
HDL
Timepoint
months 0,2,4,6
Method of measurement
blood sample
7
Description
CRP
Timepoint
months 0,2,4,6
Method of measurement
blood sample
8
Description
ALT,AST
Timepoint
months 0,2,4,6
Method of measurement
blood sample
Secondary outcomes
1
Description
taking insulin
Timepoint
months 0,2,4,6
Method of measurement
questionnaire
Intervention groups
1
Description
intervention:herbal capsule BID, for 3 months+ routine treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
office
Full name of responsible person
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?