Protocol summary
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Study aim
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The effect of powder Maa al-jobon-e aftimouni on glucose and glycosylated hemoglobin levels in patients with type 2 diabetes
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Design
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The study is a randomized, triple-blind randomized clinical trial on 104 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
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Settings and conduct
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104 patients with definite diagnosis of type 2 diabetes, referred to diabetes clinic of Arak city, were divided into 34 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.
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Participants/Inclusion and exclusion criteria
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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 70% powder) 3- Change in routine patient treatment according to physician (change in type and dose of medication used)
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Intervention groups
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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
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Main outcome variables
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Fasting blood sugar, hemoglobin glycosylated
General information
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Reason for update
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Study time update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190524043687N1
Registration date:
2020-02-25, 1398/12/06
Registration timing:
prospective
Last update:
2024-07-19, 1403/04/29
Update count:
1
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Registration date
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2020-02-25, 1398/12/06
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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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2020-04-08, 1399/01/20
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Expected recruitment end date
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2020-12-10, 1399/09/20
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Actual recruitment start date
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2020-07-03, 1399/04/13
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Actual recruitment end date
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2021-09-09, 1400/06/18
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Trial completion date
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empty
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Scientific title
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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
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Public title
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The effect of powder Maa al-jobon-e aftimouni on glucose and glycosylated hemoglobin levels
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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%
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 70%)
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)
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Age
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From 30 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
104
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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 (25 gram) 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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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. Someone 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
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Placebo
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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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2019-12-14, 1398/09/23
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Ethics committee reference number
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IR.ARAKMU.REC.1398.255
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Fasting blood sugar
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Timepoint
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Before intervention, 8 weeks after intervention
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Method of measurement
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Blood test in mg / dl
2
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Description
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Glycosylated hemoglobin
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Timepoint
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Before intervention, 8 weeks after intervention
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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 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 8 weeks
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Category
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Treatment - Drugs
2
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Description
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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 8 weeks
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Category
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Treatment - Drugs
3
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Description
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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 8 weeks
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Category
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Placebo
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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No
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Title of funding source
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Niak Pharmaceutical Company
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Proportion provided by this source
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75
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Public or private sector
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Private
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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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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available