Evaluation of the Urtica Dioica effect on blood glucose parameters and lipidprofile in patients with type 2 diabetes: a randomized double-blind clinical trial
The effect of nettle plant on blood glucose parameters and lipid profiles of patients with type 2 diabetes: a double-blind clinical trial
Design
A clinical trial with a control group, with a parallel group, random block and double-blind, will be conducted on 106 patients, each group consisting of 530 people, using online sites for random allocation, and the method of 4 blocks will be used for two groups. For the random sequence, a numerical code will be defined and people will receive the numerical code in the same order as they enter and will be placed in the corresponding group according to the block.
SPSS 23 software will be used for data analysis.
Settings and conduct
Patients with type 2 diabetes will be from the clinics affiliated to the Endocrine and Metabolism Research Institute of Tehran University. The study sample will be allocated randomly and by random block method to two groups: 1- receiving the medicine 2- receiving placebo and study conducts for three months. The trial group receive 25 mg medicine every 12 hours
Participants/Inclusion and exclusion criteria
Inclusion: having type 2 diabetes, taking oral hypoglycemic drugs, aged 30 to 65 years
Failure to enter: having type 1 diabetes, in case of insulin therapy during the last three months, and other specific types of diabetes
Intervention groups
The criteria of response to treatment, including fasting and two-hour blood sugar reduction, will be evaluated in both the intervention and placebo groups. By following up the condition of the patients for 3 months after the start of the treatment, the improvement in the control of blood sugar levels in the patients between the two intervention and placebo groups will be evaluated.
Main outcome variables
FBS
BP
HbA1C level
Anthropoid metric criteria
Kidney function
Liver function
Inflammatory factors
Serum insulin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230313057707N1
Registration date:2023-05-04, 1402/02/14
Registration timing:registered_while_recruiting
Last update:2023-05-04, 1402/02/14
Update count:1
Registration date
2023-05-04, 1402/02/14
Registrant information
Name
mohammad pazhouhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 4081
Email address
khosravi@kianpharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-19, 1401/12/28
Expected recruitment end date
2023-06-18, 1402/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Urtica Dioica effect on blood glucose parameters and lipidprofile in patients with type 2 diabetes: a randomized double-blind clinical trial
Public title
"Effect of Nettles in treatment of diabetes"
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Having diabetes type 2
Exclusion criteria:
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
106
More than 1 sample in each individual
Number of samples in each individual:
1
The studied population of people with type 2 diabetes
Randomization (investigator's opinion)
Randomized
Randomization description
Using online sites for random allocation, the method of blocks of 4 will be used for two groups. For the random sequence, a numerical code will be defined and people will receive the numerical code in the same order as they enter and will be placed in the corresponding group according to the block.
Blinding (investigator's opinion)
Double blinded
Blinding description
The test is conducted in such a way that neither the organizer nor peoples involved know any information that may affect the results.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
reasearch ethics commitees of endocrine & metabolism research institute- tehran university of medica
Street address
Flat no.4 2nd Floor no.8 Hamedan St. North kargar ave.Tehran
City
Tehran
Province
Tehran
Postal code
1418693884
Approval date
2022-04-10, 1401/01/21
Ethics committee reference number
IR.TUMS.EMRI.REC.1401.001
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
The percentage of people who have a fasting blood sugar level above 120 mg/dl, which will be checked with a blood test before starting the drug and three months later.
Timepoint
Blood test 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 test before starting the drug and three months later (after taking the drug completely)
Method of measurement
HbA1C test
2
Description
Creatinine
Timepoint
Blood test before starting the drug and three months later (after taking the drug completely)
Method of measurement
Creatinine test
3
Description
Fasting insulin
Timepoint
Blood test before starting the drug and three months later (after taking the drug completely)
Method of measurement
Fasting insulin test
4
Description
Cholesterol
Timepoint
Blood test before starting the drug and three months later (after taking the drug completely)
Method of measurement
Cholesterol test
5
Description
Triglyceride
Timepoint
Blood test before starting the drug and three months later (after taking the drug completely)
Method of measurement
Triglyceride test
Intervention groups
1
Description
Intervention group:Clinical trials of patients are followed up to 3 months after the start of treatment.The results of the tests are recorded in the questionnaire. Each patient is given the phone number of the doctor in charge so that the doctor can be contacted in case of a problem. At least two phone numbers are registered from each of the patients or their first degree relatives. The condition of the patients is followed up on a weekly basis and the tests of the patients are recorded in the questionnaire.If the condition of the patients worsens, they will be visited in person. The treatment response criteria, including fasting and two-hour blood sugar reduction, will be evaluated in both the intervention and drug groups. Attention will be paid to the possible complications of the disease, such as increase or decrease in blood sugar, and if it occurs, it will be recorded and the necessary care will be taken. By following up the condition of the patients for 3 months after the start of the treatment, the improvement in the control of blood sugar levels in the patients between the intervention and placebo groups is evaluated.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine & metabolism research institute-tehran university
Full name of responsible person
Mohammad Pazhouhi
Street address
Flat No. 3 2nd Floor No.8 Hamedan St. North Kargar Ave. Teharn
City
Tehran
Province
Tehran
Postal code
1418693884
Phone
+98 21 6694 4081
Fax
+98 21 6694 4084
Email
elhamfaghani69@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kian Pharmed Parsian
Full name of responsible person
Saeed Akbarian
Street address
Flat No 3 2nd floor No 8 Hamedan St. North Kargar Ave, Tehran Iran
City
Tehran
Province
Tehran
Postal code
1418693884
Phone
+98 21 6694 4081
Fax
+98 21 6694 4084
Email
elhamfaghani69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?