The effect of powder Maa al-jobon-e aftimouni on glucose and glycosylated hemoglobin levels in patients with type 2 diabetes referred to Arak outpatient diabetes clinic in 98
The effect of powder Maa al-jobon-e aftimouni on glucose and glycosylated hemoglobin levels in patients with type 2 diabetes
Design
The study is a randomized, triple-blind randomized clinical trial on 90 patients with type 2 diabetes. Patients in this study were divided into 3 group including intervention groups (Intermittent powder), intervention 2 (Intermittent powder) and control group
Settings and conduct
90 patients with definite diagnosis of type 2 diabetes, referred to diabetes clinic of Arak city, were divided into 30 persons group after meeting the inclusion criteria . way of randomizing groups were randomize in one step and in an easy way. The blinded individuals in this study included research associates, patients, and data analyzers. Venous blood samples were taken at the beginning and at the end of the intervention to measure fasting blood glucose and glycosylated hemoglobin. These datas will compare and evaluate in the intervention and control groups before and after the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Having Type 2 diabetes 2- Age range 30-60 years 3- No smoking and alcohol as well as no other herbal medicines 4- No chronic complications of diabetes 5- No sensitivity to milk and its components 6- Lack of Pregnancy and lactation
Exclusion criteria:
1- Hospitalization 2- Non-compliance with study protocol (to not consume less than 50% powder) 3- Change in routine patient treatment according to physician (change in type and dose of medication used)
Intervention groups
Intervention group 1:
Take 3 tablespoons daily of powder in 250 ml of warm water fasting
Intervention group 2:
One tablespoonful of powder (without diminutive) daily dissolved in 250 cc of warm water fasting
Control group:
According to the same protocol, they receive placebo powder
Main outcome variables
Fasting blood sugar, hemoglobin glycosylated
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190524043687N1
Registration date:2020-02-25, 1398/12/06
Registration timing:prospective
Last update:2020-02-25, 1398/12/06
Update count:1
Registration date
2020-02-25, 1398/12/06
Registrant information
Name
Ali Safdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 5861 5962
Email address
asafdari.nu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-12-10, 1399/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of powder Maa al-jobon-e aftimouni on glucose and glycosylated hemoglobin levels in patients with type 2 diabetes referred to Arak outpatient diabetes clinic in 98
Public title
The effect of powder Maa al-jobon-e aftimouni on glucose and glycosylated hemoglobin levels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes mellitus and full dose oral medication based on doctor prescription
Age range 30 to 60 years
Signing the consent form
Fasting blood glucose with a drug or diet between 150 and 250 mg / dl, at least 2 months before the start of the study, with a mean fasting blood glucose between 150 and 250 and HbA1c between 6.5 and 9.5% in the presence of metformin or Glibenclamide
No smoking and alcohol as well as no other herbal supplements
No chronic and various complications of diabetes based on history, examination, and paraclinical findings. And not having any chronic or advanced disease
Normal mental status and no mental disorder that impedes compliance with the study protocol
Insensitivity to milk and its components
lack of Pregnancy and lactation; And women who decide to get pregnant
Exclusion criteria:
Patient hospitalization during project implementation
Non-compliance with the study protocol (no powder consumption less than 50%)
Causes illness and complications that prevent them from continuing to study
Changes in the routine treatment of the patient according to the physician (changes in the type and dosage of drugs used, insulin therapy)
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients selected in three groups of intervention 1 and intervention 2 and control in one step and easy method, are among the patients with diabetes referred to diabetes clinic in Arak. Then the patients with equal number of members were randomly divided into three control groups (without complementary intervention and only with conventional diabetes and placebo) and intervention group 1 that in addition to usual diabetes medication, receive 3 tablespoons daily(fasting). Intervention group 2 received fasting dietary powdery mildew; intervention group 2 received 3 spoons of powdery mildew (without diminutive) daily in addition to usual diabetes medication.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients selected in three groups of intervention 1 and intervention 2 and control in one step and easy method, are among the patients with diabetes referred to diabetes clinic in Arak. Then the patients with equal number of members were randomly divided into three groups including: controls (without complementary intervention and only with usuall diabetes medication and placebo) and intervention group 1 in addition to usual diabetes medication, 3 tablespoons daily(fasting). Intervention group 2 received 3 spoons of powdery mildew (without diminutive) daily in addition to usual diabetes medication. To blind the study, placebo powder is poured into a container similar to the main drug container. So that none of the patients and researchers are in the intervention or control group know who is in which group. 90 tags containing prepared barcodes prepared, 30 barcodes for powder Maa al-jobon-e aftimouni and, 30 barcodes for powder Maa al-jobon-e aftimouni (without aftimouni), 30 barcodes for placebo, then a person other than the presenter is asked to place barcodes on the can. And keep the number of each barcode along with the placebo or its original medication and keep the sheet containing this information sealed to them without the knowledge of the designers. To be encrypted if needed during the intervention. The medicinal powders are given to the patients and the number of each drug label is recorded along with the demographic characteristics of the patients. At the end of the study, the codes assigned to patients will be adjusted to identify the type of medication, with the help of information contained in the initial sheet recorded at the beginning of the study. In fact, the blinded groups in this study included project executives, patients, and data and result analysists
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
No. Arak, Sardasht, Basij Square,Arak University of Medical Sciences
City
arak
Province
Markazi
Postal code
3848176941
Approval date
2019-12-14, 1398/09/23
Ethics committee reference number
IR.ARAKMU.REC.1398.255
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
Fasting blood sugar
Timepoint
Before intervention, 1 Month after intervention
Method of measurement
Blood test in mg / dl
2
Description
Glycosylated hemoglobin
Timepoint
Before intervention, 1 month after intervention
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1, who in addition to the usual oral medications of diabetes, Take 3 tablespoons of powder Maa al-jobon-e aftimouni daily in 250 ml of warm water fasting one hour before breakfast for 60 days
Category
Treatment - Drugs
2
Description
Intervention group 2 who in addition to the usual oral medications of diabetes, consumed 3 tablespoons of powder Maa al-jobon (without aftimouni) daily in 250 cc warm water fasting one hour before breakfast for 60 days
Category
Treatment - Drugs
3
Description
The control group, in addition to the usual oral medications of diabetes, received 3 tablespoons of placebo powder daily (based on a similar formulation produced by the pharmaceutical company) dissolved in 250 cc warm water an hour before They have breakfast for 60 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Diabetes Clinic
Full name of responsible person
Ali Safdari
Street address
Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
No. Arak, Sardasht, Basij Square,Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Niak Pharmaceutical Company
Proportion provided by this source
75
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. Arak, Sardasht, Basij Square,Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabi
Position
Member of Arak Nursing Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. Arak, Sardasht, Basij Square,Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
fmehrabi1392@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Nursing Student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. Arak, Sardasht, Basij Square,Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available