History
# Registration date Revision Id
2 2021-02-02, 1399/11/14 172287
1 2020-06-09, 1399/03/20 138189
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Determining the effect of Urtica Dioica (Nettle) on blood glucose parameters and lipid profile in patients with type 2 diabetes
Design
Double-blind randomized clinical trial with two groups: Urtica Dioica and placebo
Settings and conduct
The study will be conducted at Imam Reza Hospital. Patients will be randomly divided into two groups of Urtica Dioica and placebo by block method. The study is a double-blind (researchers and participants will not be aware of the groups involved).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 diabetes, Taking hypoglycemic drugs, Age 40-70 years, Body mass index 18.5–30 kg / m 2, Fasting blood sugar equal to or more than 126 mg / d exclusion criteria: Type 1 diabetes, Other specific types of diabetes, Insulin therapy over the past three months, Having serious gastrointestinal diseases (GI), Have a history of diabetic ketoacidosis, non-ketotic hyperosmolar diabetic coma, severe infection or surgery in the previous month, Uncontrolled high blood pressure, mental illness, Abuse or addiction to alcohol, psychoactive substances or other drugs, Pregnancy, lactation or plan to become pregnant, Having cardiovascular disease, renal insufficiency, liver dysfunction, thyroid dysfunction, parathyroid dysfunction, and cancers, High physical activity, Chronic complications of diabetes (neuropathy, retinopathy, according to patient records), diabetic nephropathy, hypothyroidism and hyperthyroidism, Sensitivity to nettle
Intervention groups
The Urtica Dioica recipient will receive a capsule (250 mg) containing 30 mg of Urtica Dioica active ingredient (Gezlin) every 12 hours. The placebo group will receive a 250 mg placebo capsule every 12 hours.
Main outcome variables
Fasting blood sugar amount that will be checked with blood tests before starting the drug and three months later (after taking the drug completely)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140617018126N3
Registration date: 2020-06-09, 1399/03/20
Registration timing: prospective

Last update: 2020-06-09, 1399/03/20
Update count: 1
Registration date
2020-06-09, 1399/03/20
Registrant information
Name
Mostafa Araj-Khodaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 9528
Email address
araj@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Urtica Dioica (Nettle) on blood glucose parameters and lipid profile in patients with type 2 diabetes: a double-blind clinical trial
Public title
The effect of Urtica Dioica (Nettle) on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes Taking hypoglycemic drugs (people who control their diabetes just by taking blood sugar-lowering drug) Age 40-70 years Body mass index 18.5–30 kg / m 2 Fasting blood sugar equal to or more than 126 mg / d
Exclusion criteria:
Type 1 diabetes Other specific types of diabetes Insulin therapy over the past three months Having serious gastrointestinal diseases (GI) including gastric ulcers and gastrointestinal bleeding Have a history of diabetic ketoacidosis, non-ketotic hyperosmolar diabetic coma, severe infection or surgery in the previous month Uncontrolled high blood pressure (Blood pressure higher or equal to 160/100 mm Hg) mental illness Abuse or addiction to alcohol, psychoactive substances or other drugs Pregnancy, lactation or plan to become pregnant Having cardiovascular disease, renal insufficiency, liver dysfunction, thyroid dysfunction, parathyroid dysfunction, and cancers High physical activity Chronic complications of diabetes (neuropathy, retinopathy, according to patient records), diabetic nephropathy, hypothyroidism and hyperthyroidism Sensitivity to nettle
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly assigned to four blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment). The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving Urtica Dioica and Placebo. Then based on blocks and allocation sequences each client will be given white pockets that are prepared in equal sizes and on which the numbers 1 to 60 are written (in order of allocation sequence). The pockets will contain white boxes containing Urtica Dioica or Placebo capsules. Only the person in charge of packing Urtica Dioica and Placebo capsules will know the numbers of the relevant pockets and none of the researchers or patients will know the type of medicine that each person receives. The first person will be given pocket number 1 and then it will continue until completion. Urtica Dioica and placebo capsules will be similar in shape, size, color and, smell
Blinding (investigator's opinion)
Double blinded
Blinding description
Based on blocks and allocation sequences each client will be given white pockets that are prepared in equal sizes and on which the numbers 1 to 60 are written (in order of allocation sequence). The pockets will contain white boxes containing Urtica Dioica or Placebo capsules. Only the person in charge of packing Urtica Dioica and Placebo capsules will know the numbers of the relevant pockets and none of the researchers or patients will know the type of medicine that each person receives. The first person will be given pocket number 1 and then it will continue until completion. Urtica Dioica and placebo capsules will be similar in shape, size, color and smell.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تبریز
Street address
تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز، ساختمان مرکزی شماره 2، طبقه سوم، معاونت تحقیقات و فناوری
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-04-20, 1399/02/01
Ethics committee reference number
IR.TBZMED.REC.1399.093

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Fasting Blood Sugar
Timepoint
Blood tests before starting the drug and three months later (after taking the drug completely)
Method of measurement
Fasting Blood Sugar Test

Secondary outcomes

1

Description
HbA1C
Timepoint
Blood tests before starting the drug and three months later (after taking the drug completely)
Method of measurement
HbA1C test

2

Description
Creatinine
Timepoint
Blood tests before starting the drug and three months later (after taking the drug completely)
Method of measurement
Creatinine Test

3

Description
Fasting Insulin
Timepoint
Blood tests before starting the drug and three months later (after taking the drug completely)
Method of measurement
Fasting Insulin Blood Test

4

Description
Cholesterol
Timepoint
Blood tests before starting the drug and three months later (after taking the drug completely)
Method of measurement
Cholesterol Test

5

Description
Triglyceride
Timepoint
Blood tests before starting the drug and three months later (after taking the drug completely)
Method of measurement
Triglyceride Test

Intervention groups

1

Description
Intervention group: This group will receive Urtica the capsules (250 mg) of Urtica Dioica containing 30 mg of the active ingredient of Urtica Dioica (Ghazlin) with the fillers every 12 hours and for 3 months. The capsules will be provided by Ghazlin Teb Company.
Category
Treatment - Drugs

2

Description
Control group: This group will receive the placebo capsules (250 mg) containing additives that will be used to make Ghazlin capsules every 12 hours and for 3 months. The capsules will be provided by Ghazlin Teb Company.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان امام رضا
Full name of responsible person
Seyed Mostafa Araj khodaie
Street address
خیابان گلگشت، روبروی سازمان مرکزی دانشگاه علوم پزشکی تبریز، بیمارستان امام رضا
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 2178
Email
aria@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
محمد سمیعی
Street address
Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mostafa Araj-Khodaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Aging Research Institute, Faculty of medicine, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 2178
Email
araj@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mostafa Araj-Khodaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Aging Research Institute, Faculty of medicine, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 2178
Email
araj@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mostafa Araj-Khodaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Aging Research Institute, Faculty of medicine, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 2178
Email
araj@tbzmed.ac.ir
Web page address

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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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