Investigating the effect of nettle extract on metabolic parameters and insulin resistance in obese children
Design
The clinical trial has a control group, with parallel groups, a blind strain, randomized, on 64 patients, and SAS version 9 software is used for randomization with 4 permuted block randomization method.
Settings and conduct
The study will be conducted in 17 Shahrivar hospital (endocrine department) in two intervention and control groups. The patients are not blind to the treatment group and are only researchers and statistics experts analyzing the information blind to the treatment group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children 12 to 18 years old
BMI greater than 85th percentile for age and sex
Lack of sensitivity to nettle and its products (if exposed and reported by the patient)
Not suffering from hypotension (lower blood pressure less than 90 on 60 mm Hg)
Absence of heart and kidney failure (according to medical examinations and laboratory results)
Exit criteria:
The patient's unwillingness to participate in the study
Patient taking lithium, warfarin and antihypertensive drugs
Fluid retention due to reduced heart and kidney function
Intervention groups
The first group receives 5 cc of nettle syrup twice a day along with the diet, and the second group follows the diet alone. The duration of the intervention is 12 weeks and all patients are monitored weekly and monthly by pediatric endocrinologists.
Main outcome variables
Fasting blood sugar, fasting blood insulin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054879N3
Registration date:2022-12-25, 1401/10/04
Registration timing:registered_while_recruiting
Last update:2022-12-25, 1401/10/04
Update count:0
Registration date
2022-12-25, 1401/10/04
Registrant information
Name
maryam shahrokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9026
Email address
mshahrokhi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of nettle (urtica dioica) extract on medical parameters and insulin resistance in pediatric patients with obesity
Public title
effect of nettle extract on insulin resistance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 12 to 18 years old
BMI greater than 85th percentile for age and sex
Allergy to nettle and its products (if exposed and reported by the patient)
Not suffering from hypotension (lower blood pressure less than 90 on 60 mm Hg)
Absence of heart and kidney failure (according to medical examinations and laboratory results)
Exclusion criteria:
patient reluctance to participate in the study,
Patient taking lithium, warfarin and antihypertensive drugs,
Fluid retention due to reduced heart and kidney function
Age
From 12 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Type of randomization, details of any restrictions (such as blocking and block size):
Permuted block randomization method of 4 is used to randomize people in two groups. Considering that group A is the intervention group and group B is the control group.The randomization process will be as follows. The entire randomization file is available as an Excel file (randomization was done with SAS software version 9)
The method used to generate a random allocation sequence by mentioning the name of the software or site used:
Randomization was done with SAS software version 9
Allocation concealment method:
Group assignment will be done through closed envelopes.
Randomization implementation process:
The randomization process will be carried out under the supervision of the project manager and by him and with the direct supervision of the statistician and the supervisor.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since it is not possible to make a placebo for us due to the taste and smell of the product; One group of patients receives nettle syrup in addition to following the diet, and in the other group, only the diet is controlled.Therefore, the patients are not blinded to the treatment group, and they are only researchers and statistical experts analyzing the information blinded to the treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gilan University of Medical Sciences
Street address
Rasht-Namjo Street-Shahid Siadati Street-in front of 17 Shahrivar Hospital-Deputy for Research and Technology
City
Rasht
Province
Guilan
Postal code
4193713111
Approval date
2022-12-07, 1401/09/16
Ethics committee reference number
IR.GUMS.REC.1401.458
Health conditions studied
1
Description of health condition studied
Insulin resistance - obesity - children
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
fasting blood suger
Timepoint
month 0, 1, 3
Method of measurement
blood test
2
Description
Fasting insulin levels
Timepoint
month 0, 1, 3
Method of measurement
blood test
3
Description
Homa insulin resistance factor
Timepoint
month 0, 1, 3
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to following the diet, nettle syrup (hydroalcoholic extract) of Zarband company is received in the form of 5 cc twice a day for 12 weeks.
Category
Treatment - Other
2
Description
Control group: the diet alone is observed for 12 weeks
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
17 shahrivar hospital
Full name of responsible person
Maryam Shahrokhi
Street address
Rasht - Namjo Street - Shahid Siyadati Street - 17 Shahrivar Hospital
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3336 9019
Email
17shahrivar@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Rasht - Namjo Street - Shahid Siyadati Street - in front of 17 Shahrivar Hospital
City
Rasht
Province
Guilan
Postal code
4193713111
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Maryam Shahrokhi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Rasht - Namjo Street - Shahid Siyadati Street - 17 Shahrivar Hospital
City
Rasht
Province
Guilan
Postal code
414465379
Phone
0098133369019
Email
shahrokhi.mail85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Maryam Shahrokhi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Rasht - Namjo Street - Shahid Siyadati Street - 17 Shahrivar Hospital
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3336 9019
Email
shahrokhi.mail85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Khalatbari
Position
Pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Rasht - Hafez Street - Ghalamestan 3 - Ali Building
City
Rasht
Province
Guilan
Postal code
4145695715
Phone
+98 901 533 0905
Email
zahrakhalatbari6@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Preservation of patients' privacy and compliance with ethical principles
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the study will be available to everyone. Exclusive information will be available only to the treatment staff. To respect the privacy of the patient, the patient's information will be kept by the researcher.
When the data will become available and for how long
Currently, there is no plan to publish the data, but if it is published, it will be 6 months after the results are published.
To whom data/document is available
Researchers who are active in this field, pediatric specialists and scientific and qualified people
Under which criteria data/document could be used
Doctors and researchers will have the right to request, there are restrictions in order to protect the patient's privacy and comply with medical ethics
From where data/document is obtainable
17 Shahrivar Hospital, Rasht - Dr. Maryam Shahrokhi, Faculty of Pharmacy, Gilan Medical Sciences - Zahra Khalatbari
What processes are involved for a request to access data/document
Go to 17 Shahrivar Hospital in Rasht and sign the application form, then meet with the researcher of the plan and review the application of the referring person, consult with the ethics committee in medicine and then submit the documents.