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IRCT20201026049154N1 IRCT 2020-11-08 Gorgan University of Medical Sciences The effect of okra powder on blood sugar levels in pre-diabetic patients Study of Okra( Abelmoschus esculentus ) Powder effects on Glucose Level, inflammatory factors ( IL-6،TNF- 2020-11-21 anticipated 80 Complete https://irct.ir/trial/51880 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization, using Excel software by computer, 80 random numbers with frequency A and B are generated in a row. Now, the researcher places the patient in one of these two groups of patients, from 1 to 80, depending on whether it is A or B for each of the cultivars, Blinding description: The patient does not know whether he is in the intervention group or placebo. The treating physician is not aware of how the patient is randomized to receive medication or placebo. The researcher and statistical consultant will not be aware of the intervention and placebo groupings. 3 Pre-diabetes. Intervention 1: Intervention group: 500 mg okra powder capsules, two capsules, three times a day, half an hour before meals, orally for at least 8 weeks for randomized patients in this group will be prescribed. Blood samples will be taken from all patients before the intervention and after the intervention to perform tests. Intervention 2: Placebo group: 500 mg carboxymethylcellulose capsules, two capsules, three times a day, half an hour before meals, orally for at least 8 weeks for randomized patients in this group. Blood samples will be taken from all patients before the intervention and after the intervention to perform tests. Yes - There is a plan to make this available What will be shared: For the sake of transparency in the research process, all data can potentially be shared after identifying individuals. When: Access period starts 6 months after the results are published To whom: The data obtained from this research can be used by different segments of the population. Conditions: There are no restrictions on the use of data obtained from this study. Where to obtain: The data obtained from this study are available in information databases. How to obtain: The data from this study are subject to public disclosure in the database without any restrictions, so no specific request or process is required. Comments:
public Mohammad Reza Afsharmanesh
Gorgan Jadid IV - Bahmaninejad Alley - Mahtab Building - Unit 6
Gorgan Iran (Islamic Republic of) 4913816364 +98 916 616 2697 mra448@yahoo.com Gorgan University of Medical Sciences scientific Azad Reza Mansoorian
Hyrkan Blvd.-Kelestan University of Medical Sciences -Medical School of Biochemistry
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 1653 azad_r_mansourian@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Fasting blood sugar between 100 and 125 mg per deciliter 30 years 55 years Both Pregnancy and lactation in women Existence of mental disorders at the same time that make it difficult to cooperate Concomitant diseases such as heart disease, renal failure, thyroid disease, inflammatory diseases and allergies Taking non-steroidal anti-inflammatory drugs Taking steroid drugs Treatment - Drugs Placebo Intervention group: 500 mg okra powder capsules, two capsules, three times a day, half an hour before meals, orally for at least 8 weeks for randomized patients in this group will be prescribed. Blood samples will be taken from all patients before the intervention and after the intervention to perform tests. Placebo group: 500 mg carboxymethylcellulose capsules, two capsules, three times a day, half an hour before meals, orally for at least 8 weeks for randomized patients in this group. Blood samples will be taken from all patients before the intervention and after the intervention to perform tests. Reduce fasting blood sugar. Timepoint: At the beginning of the study and after 8 weeks of consumption of okra powder. Method of measurement: Blood sample analysis. HbA1C. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Blood sample analysis. Measurement of interleukin 6 (one of the inflammatory factors) in the blood. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Blood sample analysis. Measurement of blood TNF-. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Blood sample analysis. Evaluation of miR-15a expression (one of the diabetes-related miRs). Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: With Real-time pcr method. Expression of miR-126 expression (one of the diabetes-related miRs). Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: With Real-time pcr method. Gorgan University of Medical Sciences Approved 2020-10-04 Ethics Committee of Golestan University of Medical Sciences Gorgan - Hyrkan Boulevard - Golestan University of Medical Sciences Gorgan Golestan Iran (Islamic Republic of)