Protocol summary

Study aim
Evaluation of the Effect of pistaciakhinjuk leaves billardieri on metabolic control and quality of life in type 2 diabetic patients referred to traditional medicine clinics of Isfahan city in 2019.
Design
Clinical trial with control and experimental groups, with parallel groups, random selection, phase 2 on 72 patients
Settings and conduct
Diabetes is the most common metabolic disease in the world. It has been dubbed the "latent epidemic" by the World Health Organization. According to the International Diabetes Federation, the prevalence of diabetes in people over the age of 18 in the world in 2014 was estimated at 9% . In Iranian clinics affiliated to Isfahan University of Medical Sciences (Sedigheh Tahereh Endocrine and Metabolism Center), it is performed randomly by the experimental group using Kalkhang tea.
Participants/Inclusion and exclusion criteria
Type 2 diabetes and the use of oral antihypertensive drugs are approved by your doctor. No insulin injection Have a history of at least 2 years of diabetes Have an age range between 30 and 60. Have taken oral antihypertensive drugs at least three months ago. The patient's body mass index should be less than 30. ؛ The woman is pregnant. Be breastfeeding over time. HBA1C hemoglobin in the last three months of the patient is 6.5% _ 5.5%
Intervention groups
The experimental group consumes 5 grams of kale leaf every 24 hours for 1 month and the control group proceeds according to their usual treatment. The average fasting blood sugar test at the beginning of the study, 1 month and a month later, as well as the percentage of hemoglobin A1C at the beginning of the study and 3 months after all, will be taken.
Main outcome variables
Determination and comparison of kohlrabi on mean fasting plasma glucose, mean glycosylated hemoglobin (HBA1C) and quality of life in type 2 diabetic patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210801052040N1
Registration date: 2021-08-08, 1400/05/17
Registration timing: retrospective

Last update: 2021-08-08, 1400/05/17
Update count: 0
Registration date
2021-08-08, 1400/05/17
Registrant information
Name
kobra afzali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7533
Email address
kosarafzali96@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-29, 1399/01/10
Actual recruitment start date
2021-02-28, 1399/12/10
Actual recruitment end date
2021-05-31, 1400/03/10
Trial completion date
2021-06-20, 1400/03/30
Scientific title
Evaluation of the Effect of pistaciakhinjuk leaves billardieri on metabolic control and quality of life in type 2 diabetic patients .
Public title
Evaluation of the Effect of pistaciakhinjuk leaves billardieri on metabolic control and quality of life.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes and taking oral hypoglycemic drugs No insulin injection Have a history of at least 2 years of diabetes Have an age range between 30 and 60 Have taken oral antihypertensive drugs at least three months ago. The patient's body mass index should be less than 30. Willing to participate in research.
Exclusion criteria:
The woman is pregnant. During lactation. Hemoglobin HBA1C in the last three months is 6.5% - 5.5%.
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 72
Actual sample size reached: 72
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a clinical trial in an easy and accessible method, then in the form of random block allocation, which is the most practical method of quadruple blocks in the blocking method. In this trial, the intervention group is group A and the control group is group B. In each block, waiting We have to be AABB. In this block layout, the combination of blocks as 1. AABB 2. ABAB 3. ABBA 4. BBAA 5. BABA 6, BAAB is divided. To make randomization completely unpredictable. Moving in a random number table should be from top to bottom, from left to right or right to left. According to these 6 blocking modes, we refer to the table of random numbers. For example, in the table of random numbers, the first block is AABB, which according to the table of random numbers is 1. AABB 1321. In this way, the number 1 of the intervention, the number 3 of the intervention, the number 2 of the control, the number 9 are deleted because the block modes are 6, then the number 1 is the control group and so on the other 9 blocks according to the random number table. We go and the samples are selected. From each of the studied groups and from the patients referring to the Iranian medicine clinics of the hospitals affiliated to Isfahan University of Medical Sciences who have the inclusion criteria, which will be done by block random allocation method in 2 control and test groups. we put. The experimental group takes herbal medicines under the supervision of a traditional medicine specialist and the dose of chemical medicines is adjusted by the doctor. The control group is taking oral medication under the supervision of a physician.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Central Headquarters
City
Esfahan
Province
Isfehan
Postal code
031-3668-0048
Approval date
2020-06-10, 1399/03/21
Ethics committee reference number
IR.MUI.RESERCH.REC.1399.136

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
ICD-10 code description
Type 2 diabetes,

Primary outcomes

1

Description
Metabolic control indicators and quality of life
Timepoint
Fasting blood sugar before the intervention, 1 month and 3 months later; Hemoglobin (A1C) before intervention and 3 months after
Method of measurement
Lancet glucometer, Jacobson Diabetes Quality Of Life

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Kalkhang leaf tea, 120 cc of 5 grams Kalkhang leaf tea 2 times in 24 hours (after breakfast and dinner) for 1 month.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sedigheh Tahereh Endocrinology and Metabolism Center, Isfahan
Full name of responsible person
Sasan Haghighi
Street address
Isfahan - Jomhory Square - Khorram St. - after the intersection of martyrs - Hazrat Sedigheh Tahereh Educational, Therapeutic and Research Complex - Ground Floor - Endocrine and Metabolism Research Center
City
Esfahan
Province
Isfehan
Postal code
81876-98191
Phone
+98 31 3335 9933
Email
emrc@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fakhri Saboohi
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Esfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
sabohi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
80
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
Esfahan University of Medical Sciences
Full name of responsible person
Fakhri Saboohi
Position
the coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Esfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
sabohi@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fakhri Sabohi
Position
the coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
sabohi@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
kobra afzali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Resalat Boulevard, 13th Alley
City
Lordegan
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8891697644
Phone
+98 38 3444 9675
Email
kosarafzali96@mui.ac.ir

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
There is 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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