Protocol summary
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Study aim
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Due to that the major human studies performed in patients with type 2 diabetes, as well as the limited human studies and different results of previous studies, this study will be conducted to investigate the effect of nettle extract on blood sugar control and insulin dose in patients with type 1 diabetes.
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Design
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The clinical trial has a control group, with parallel groups, double-blind, randomized, on 50 patients and the https://www.sealedenvelope.com website is used for randomization.
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Settings and conduct
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Will be performed in 17 Shahrivar Hospital of Rasht. (Endocrinology Department)
The study will be conducted in two groups of intervention and control. Researchers, and data analysts will be blind.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
12-18 years old Patients with type 1 diabetes treated with insulin and with improper blood sugar control (A1C greater than 6.5 mg / dl) provided that their BUN and serum creatinine are satisfactory and the patient does not classified as a patient with renal impairment.(BUN 8-20 mg / dL and creatinine less than 1.5 mg / dL.)
Exclusion criteria:
Patient disinclination
Patient taking lithium, warfarin and antihypertensive drugs due to drug interactions according to who source
History of previous allergies to nettle edible products
Changes more than 0.3 units in patient renal function parameters
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Intervention groups
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The first group receives insulin with 5 cc of nettle syrup twice a day and the second group receives insulin alone. The duration of intervention is 12 weeks and all patients are monitored weekly and monthly by pediatric endocrinologists.
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Main outcome variables
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Fasting blood sugar, A1C
General information
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Reason for update
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Regarding the insufficient cooperation of children, using placebo was impossible.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220516054879N2
Registration date:
2022-07-06, 1401/04/15
Registration timing:
prospective
Last update:
2023-03-08, 1401/12/17
Update count:
1
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Registration date
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2022-07-06, 1401/04/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-07-23, 1401/05/01
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Expected recruitment end date
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2022-11-22, 1401/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effect of extract of nettle (Urtica Dioica) on blood glucose in adolescent patients with type 1 diabetes , A Randomized Double Blinded Controlled Trial
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Public title
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Evaluation of the effect of extract of nettle (Urtica Dioica) on blood glucose in adolescent patients with type 1 diabetes , A Randomized Double Blinded Controlled Trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
12-18 years old Patients with type 1 diabetes treated with insulin
and with improper blood sugar control (A1C greater than 6.5 mg / dl)
provided that their BUN and serum creatinine are satisfactory and the patient does not classified as a patient with renal impairment.(BUN 8-20 mg / dL and creatinine less than 1.5 mg / dL.)
Exclusion criteria:
Patient reluctance
Patient taking lithium, warfarin and antihypertensive drugs Due to the existence of drug interactions according to the WHO source
History of previous allergies to nettle edible products
Change of more than 0.3 units in the parameters of patient's renal function
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Age
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From 12 years old to 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization type, details of any restrictions (such as blocking and block size):
Due to the equality and lack of diagnosis of the type of treatment by the participants, the block randomization method will be used. According to the number of sample sizes, the size of the blocks is 4.
The method used to generate a random allocation sequence using the name of the software or site used:
Random blocking will be assigned to research units in numbers 1 to 30, respectively. Then a table with 6 rows called blocks and each block will have 5 sections and each section will be named with A and B, will be considered. In the next step, the numbers are placed in each house in order. After all the numbers are placed in the blocks, the people who had the number in house A will receive the intervention medicine and the people who had the number in house B will be considered as the control group. The website https://www.sealedenvelope.com is used for randomization.
Allocation Concealment method:
The numbered Sequentially Envelopes: sealed, opaque envelopes method is used to hide random allocation.
Randomization process (who will determine the random allocation sequence, who will register participants, who will assign participants to interventions):
The randomization process will be performed under the supervision of the project manager and by him and with the direct supervision of a statistician and the supervisor.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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the investigator and data analyzer were blinded.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-06-01, 1401/03/11
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Ethics committee reference number
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IR.GUMS.REC.1401.113
Health conditions studied
1
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Description of health condition studied
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Type 1 diabetes - insulin - children
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ICD-10 code
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E10
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ICD-10 code description
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Insulin-dependent diabetes mellitus
Primary outcomes
1
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Description
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fasting blood glucose sugar reduction
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Timepoint
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The variable will be measured at the beginning of the study, 4, 8 and 12 weeks after the start of the study.
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Method of measurement
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Home glucose testing devices or blood tests
Secondary outcomes
1
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Description
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A1C reduction
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Timepoint
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This variable will be measured at the beginning of the study and 12 weeks after the start of the study.
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Method of measurement
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blood test
2
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Description
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Insulin dose reduction
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Timepoint
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This variable will be measured at the beginning of the study and 12 weeks after the start of the study.
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Method of measurement
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blood test
Intervention groups
1
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Description
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Intervention group received insulin with 5 cc of zardband company nettle syrup (Hydroalcoholic extract) twice a day for 12 weeks.
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Category
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Treatment - Other
2
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Description
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Control group received routine insulin
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Rasht University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Patient privacy and ethical principles
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The results of the study will be available to everyone, specific information will be available only to the treatment staff. To protect the patient's privacy, the patient's information will be protected by the researcher.
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When the data will become available and for how long
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There is currently no plan to publish the data, but if published, it will be 6 months after the results are published.
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To whom data/document is available
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Researchers working in this field - pediatricians and scientists with qualifications
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Under which criteria data/document could be used
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Physicians and researchers will have the right to request, there are restrictions on patient privacy and medical ethics
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From where data/document is obtainable
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Dr. Maryam Shahrokhi-17 Shahrivar Hospital, Rasht
Reyhaneh Haghi - School of Pharmacy guilan university of meical science
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What processes are involved for a request to access data/document
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Refer to the 17 Shahrivar Hospital in Rasht and sign the application form, then meet with the project researcher and review the client's request - consult with the Medical Ethics Committee, then provide documentation
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Comments
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