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IRCT20190525043704N1 IRCT 2019-09-23 Abadan University of Medical Sciences Effect of F. assa-foetida in Diabetese Comparison of the Effectiveness of F. assa-foetida and Placebo on Antihyperglycemic, Antihyperlipidemic, Anti-inflammatory, and Antioxidant Activities in Type 2 Diabetes Mellitus Patients 2019-12-05 anticipated 66 Complete https://irct.ir/trial/40762 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: This study was designed as a double-blind randomized, placebo-controlled clinical trial. Samples will be selected from an outpatient referral to a private clinic that has been consulted by an internal medicine specialist, Type 2 diabetes mellitus has been approved by the physicin, and have provided the inclusion criteria of the study. Diabetic patients who are willing to participate in the study and complete the consent form will be enrolled in the study, Randomization description: The random allocation of the participants to the intervention and control groups will be done using random allocation software. Then, envelopes prepare according to the number of participants in the study. It will be recorded number one on the first envelope, the second envelope number 2, and etc. In each envelope, the assignment of each individual is determined by the software. In this way, the specified envelope for each individual will be opened and the individual will be assigned to one of the intervention and/or control groups according to the option recorded in the envelope, Blinding description: Participants and researchers will not informed about the assigned group (double blind). The placebo will also be used in the control group to control the effect of induction following the administration of the capsules. 0 (exploratory trials) Type 2 diabetes mellitus. Intervention 1: Intervention group: Receiving F. assa-foetida capsule called Asafin at dose of 250 mg twice daily for 3 mounts. It is necessary to mention that standard treatment is glucose lowering drugs such as glibenclamide and metformin and all subjects should receive standard treatment. Drug formulation: Studies on animal and human species used the plant's resin to determine the effects of the drug. Due to the unpleasantness of this part of the plant for the patient and the likelihood of decreasing the adaptation, according to the drug formulation used in the similar study, 250 mg of the root and seed of the plant in powder form will be used to make Asafin capsule. The drug will be formulated by the Pharmacology Laboratory of the Faculty of Pharmacy, Ahwaz University of Medical Sciences, Ahwaz, Iran. Intervention 2: Control group: Receiving placebo capsule (starch) at a dose of 250 mg twice daily for 3 mounts. It is necessary to mention that standard treatment is glucose lowering drugs such as glibenclamide and metformin and all subjects should receive standard treatment. The placebo will be formulated by the Pharmacology Laboratory of the Faculty of Pharmacy, Ahwaz University of Medical Sciences, Ahwaz, Iran. No - There is not a plan to make this available Justification or reason for not sharing IPD is As stated in the consent form of the research, the researchers involved in the study kept all information about the patient confidential and are only allowed to publish the general and group results of this research without mentioning their names and specifications. Patients also know that they can have their own personalized results.
public Mahshid Naghashpour
Airport Ave., Abadan, Iran
Abadan Iran (Islamic Republic of) 6318887544 +98 61 5326 5358 mnaghashpour@gmail.com Abadan Faculty of Medical Sciences scientific Mahshid Naghashpour
No, 1831, Kasra lane, South Bovardeh Ave
Abadan Iran (Islamic Republic of) 6318887544 +98 61553230046 mnaghashpour@gmail.com Abadan University of Medical Sciences Iran (Islamic Republic of) Age 25-25 years Male and female patients Completion of diagnostic criteria for type 2 diabetes mellitus The desire to participate in the study with the ability to understand the relevant information and complete the informed consent form 25 years 85 years Both Use of warfarin and other coumarin substitutes by the patient Use of increasing blood glucose drugs such as antidepressants (triangles), beta-adrenergic blockers, corticosteroids, diazoxide, diuretics, epinephrine, estrogen, glucagon, isoniazid, lithium, phenothiazines, phenytoin, salicylates and triamterene Use of glucose lowering drugs, including acetaminophen, alcohol, anabolysin steroids, gemfibrosil, monoamine oxidase inhibitors, propranolol, tolazamide, and tolbutamide History of uncontrolled hypertension, congestive heart failure and other cardiovascular disease, liver disease, kidney disease, or any metabolic and clinical disorder, except diabetes mellitus Patients with dangerous disease Renal dysfunction (glomerular filtration rate less than 60 ml / min / 1.73 mm3 of surface area) Participants with recent weight loss or weight gain more than 5% of body weight within 3 months People with type 1 diabetes or other chronic diseases such as stroke and cancer that may affect physical activity Pregnant and lactating women People with psychological illnesses Patient with type 2 diabetes under insulin therapy Smoking during the testing period (increasing blood glucose levels) Patients with sickle cell anemia, thalassemia, Chronic renal failure affecting the hemoglobin A1c Any circumstances that, according to the researcher, do not justify the participation of individuals in the study E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: Receiving F. assa-foetida capsule called Asafin at dose of 250 mg twice daily for 3 mounts. It is necessary to mention that standard treatment is glucose lowering drugs such as glibenclamide and metformin and all subjects should receive standard treatment. Drug formulation: Studies on animal and human species used the plant's resin to determine the effects of the drug. Due to the unpleasantness of this part of the plant for the patient and the likelihood of decreasing the adaptation, according to the drug formulation used in the similar study, 250 mg of the root and seed of the plant in powder form will be used to make Asafin capsule. The drug will be formulated by the Pharmacology Laboratory of the Faculty of Pharmacy, Ahwaz University of Medical Sciences, Ahwaz, Iran. Control group: Receiving placebo capsule (starch) at a dose of 250 mg twice daily for 3 mounts. It is necessary to mention that standard treatment is glucose lowering drugs such as glibenclamide and metformin and all subjects should receive standard treatment. The placebo will be formulated by the Pharmacology Laboratory of the Faculty of Pharmacy, Ahwaz University of Medical Sciences, Ahwaz, Iran. Fasting blood sugar. Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Colorimetric method using spectrophotometer. 2 hour post prandial. Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Colorimetric method using spectrophotometer. At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Calorimetry with ELISA reader. Serum glutathione peroxidase enzyme activity. Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Calorimetry with ELISA reader. Serum catalase enzyme activity. Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Calorimetry with ELISA reader. Serum LDL level. Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Colorimetric method using spectrophotometer. Serum HDL levels. Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Colorimetric method using spectrophotometer. Serum total cholestrol. Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Colorimetric method using spectrophotometer. Serum triglyceride levels. Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Colorimetric method using spectrophotometer. Body weight. Timepoint: At the beginning of the study (before the start of the study), on days 45 and 90 after the start of taking the Asafin capsule. Method of measurement: Scales. Waist circumference. Timepoint: At the beginning of the study (before the start of the study), on days 45 and 90 after the start of taking the Asafin capsule. Method of measurement: Meter strip. Waist to hip ratio (WHR). Timepoint: At the beginning of the study (before the start of the study), on days 45 and 90 after the start of taking the Asafin capsule. Method of measurement: Calculate the ratio. Body Mass Index (BMI). Timepoint: At the beginning of the study (before the start of the study), on days 45 and 90 after the start of taking the Asafin capsule. Method of measurement: Calculate the ratio of weight to squared height. High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Calorimetry with ELISA reader. Erythrocyte sedimentation rate (ESR). Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: erythrocyte sedimentation rate. Malondialdehyde(MDA). Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Calorimetry with ELISA reader. Advanced glycation end-products (AGEs). Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: ELISA and ELISA reader. Serum glutamic oxaloacetic transaminase (SGOT). Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Colorimetric method using spectrophotometer. Serum glutamic-pyruvic transaminase (SGPT). Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Colorimetric method using spectrophotometer. Glycated hemoglobin (Hb A1c). Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: Colorimetric method using spectrophotometer. Serum leptin level. Timepoint: At the beginning of the study (before the start of the study) and 90 days after the start of taking the Asafin capsule. Method of measurement: ELISA and ELISA reader. Abadan University of Medical Sciences Approved 2019-07-09 Ethics commiittee of Abadan facukty of medical sciences Airport Ave. Abadan Khouzestan Iran (Islamic Republic of)