The objective of this study is to determine the effect of distillate of urtica dioica leaves on blood glucose of patients with type 1 diabetes. A total of 30 patients with known type 1 diabetes, will be recruited in a clinical trial. Sample size consists of 30 patients. The patients are studied for 6 days. During the first three days, they don’t receive any intervention and the baseline measures will be determined. They will take urtica distillate on the second three days. The carbohydrate counting of their foods will be equal on these two periods. The blood glucose will be monitored by continuous glucose monitoring system every 5 minutes on these 6 days. The patients are assigned to 10 groups of 3 patients each. The first group will receive 15 ml/M2 of the substance and next groups will receive 15 mL more than the previous group until the effect of substance or an adverse event appears. Total daily blood glucose and insulin will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008174585N1
Registration date:2011-02-03, 1389/11/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-03, 1389/11/14
Registrant information
Name
Maryam Razzaghy-Azar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 2903
Email address
mrazar@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-03-23, 1390/01/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of distillate of Urtica Dioica leaves on blood sugar of patients with type 1 diabetes mellitus
Public title
The effect of distillate of Urtica Dioica leaves on blood sugar of patients with type 1 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of type 1 diabetes mellitus who are on the treatment with insulin, duration of diabetes equal or more than one year from the diagnosis, age more than 10 years, no chronic complication of diabetes, no systemic or concomitant disease
Exclusion criteria: any stressful situation such as trauma, infectious disease, surgery, or acute illness
Age
From 10 years old to 20 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of medical faculty of Tehran University of Medical Sciences
Street address
East Hemmat Exp. Way between Sheikh Fazlolah and Shahid Chamran
City
Tehran
Postal code
1449614535
Approval date
2010-06-07, 1389/03/17
Ethics committee reference number
P/883
Health conditions studied
1
Description of health condition studied
diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
blood glucose
Timepoint
Every 5 minutes
Method of measurement
continuous glucose monitoring system
2
Description
total daily dose of insulin
Timepoint
daily
Method of measurement
record of total daily dose
Secondary outcomes
1
Description
blood pressure
Timepoint
daily
Method of measurement
blood pressure measurment device
2
Description
clinical manifestations and complaints
Timepoint
daily
Method of measurement
physical examination and medical history
Intervention groups
1
Description
The patients are assigned to 10 groups of 3 patients each. The first group will receive 15 ml/M2 of the substance and next groups will receive 15 mL more than the previous group until the effect of substance or an adverse event appears.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
H. Aliasghar Children's Hospital
Full name of responsible person
Prof. Maryam Razzaghy Azar
Street address
East Dastgerdi St. Modarres Exp. Way
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences (Pardis Hemmat)
Full name of responsible person
Dr Akbar Fotouhi
Street address
East Hemmat High Way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences (Pardis Hemmat)
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
Tehran University of Medical Sciences
Full name of responsible person
Prof. Maryam Razzaghy-Azar
Position
Specialty in Pediatrics Subspecialty in Pediatric Endocrinology and Metabolism
Other areas of specialty/work
Street address
No. 23 Setareh Alley, North Kargar Ave.
City
Tehran
Postal code
1418654941
Phone
+98 21 6694 2903
Fax
+98 21 6642 1054
Email
mrazar@tums.ac.ir, mrazar_md@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Maryam Razzaghy-Azar
Position
Professor of Pediatrics and Pediatric Endocrinology and Metabolism
Other areas of specialty/work
Street address
No. 23, Setareh Alley, North Kargar Ave.
City
Tehran
Postal code
1418654941
Phone
+98 21 6694 2903
Fax
+98 21 6642 1054
Email
mrazar@tums.ac.ir, mrazar_md@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Maryam Razzaghy-Azar
Position
Professor of Pediatrics and Pediatric Endocrinology and Metabolism
Other areas of specialty/work
Street address
No. 23, Setareh Alley, North Kargar Ave
City
Tehran
Postal code
1418654941
Phone
+98 21 6694 2903
Fax
+98 21 6642 1054
Email
mrazar@tums.ac.ir , mrazar_md@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)