This study evaluates the effect of Urtica Dioica leaves extract on glycemic control in patients with type 1 diabetes mellitus and is adouble blind clinical trial with participation of 64 children with type I diabetes mellitus, referred to endocrine clinic of Gorgan Taleghani hospital.Those patients who meet the inclusion criteria, after Obtaining informed consent, will be enrolled in the study. After obtaining HgA1C level and other necessary laboratory tests, the patients will randomly assign to either the intervention group or the control group (32 patients per group). In the intervention group nettle extract in form of capsules will be given at dose of 100 mg/m2 and the control group will receive placebo at same dose for 3 months, along with their usual dose of insulin. During the study, patients will be followed with phone calls and frequent visits. At the end of 3 months, HgA1C and other laboratory tests will be repeated and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412084585N7
Registration date:2015-03-03, 1393/12/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-03, 1393/12/12
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
Golestan University of Medical sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Urtica Dioica leaves extract on glycemic control in patients with type 1 diabetes mellitus
Public title
Effect of Nettle extract on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :diagnosis of T1DM based on ADA criteria; at least 6 months have passed since diagnosis of diabetes; age 6 to 16 years; no other underlying disease
Exclusion criteria :inappropriate use of nettle; Parents lack the necessary cooperation and regular visits; diagnosis of other disease during study period; drug intolerance or occurrence of side effects necessitating drug discontinuation; use of other drugs such as herbal formulas or complementary vitamins
Age
From 6 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Golestan University of Medical Sciences
Street address
Falsafi educational department, Shast kola avenue
City
Gorgan
Postal code
Approval date
2014-09-02, 1393/06/11
Ethics committee reference number
1479179306197
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
HbA1C
Timepoint
3 Months
Method of measurement
percent of glycosylated hemoglobin
Secondary outcomes
1
Description
Insulin
Timepoint
3 Months
Method of measurement
Units of insulin
Intervention groups
1
Description
For intervention group nettle capsules with dose of 100mg/m2 are given orally along with insulin injections.
Category
Treatment - Drugs
2
Description
For control group placebo capsules with dose of 100mg/m2 are given orally along with insulin injections.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Children Hospital
Full name of responsible person
Dr.Hosein Zaeri
Street address
City
Goragn
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Doctor Masoud Khoshnia
Street address
Falsafi educational department, Shast kola avenue
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Sciences
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
Endocrinology and Metabolism Research Institute
Full name of responsible person
Doctor Neda Mehrdad
Street address
Endocrinology and Metabolism Research Institute, Shariati Hospital, North Karegar Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Institute
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
Golestan University of Medical Sciences
Full name of responsible person
Doctor Hosein Zaeri
Position
Assistant Professor of Pediatrics and Pediatric Endocrinology and Metabolism
Other areas of specialty/work
Street address
Janbazan boulvard, Taleghani Children Hospital
City
Gorgan
Postal code
Phone
+98 17 3222 7720
Fax
Email
Dr.zaeri@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
Professor 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 Avenue
City
Tehran
Postal code
Phone
+98 21 6694 2903
Fax
Email
mrazar@tums.ac.ir, mrazar_md@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan university of Medical Sciences
Full name of responsible person
Doctor Hosein Zaeri
Position
Assistant Professor of Pediatrics and Pediatric Endocrinology and Metabolism
Other areas of specialty/work
Street address
Taleghani Children Hospital, Janbazan bulvard
City
Gorgan
Postal code
Phone
+98 21 3222 7720
Fax
Email
Dr.zaeri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)