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IRCT20210914052480N1 IRCT 2022-07-06 Bagheiat-allah University of Medical Sciences effect of sugarheal in patients with prediabetic situation A Comparison Between the Effect of Sugar Heal and Metformin on Fasting Blood Sugar (FBS), 2-hours Postprandial Sugar, Low density lipoprotein and Urea in Pre-diabetic Patients. 2022-07-23 anticipated 100 Complete https://irct.ir/trial/61046 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization would be done with 4 units blocks, Blinding description: Medications are received in similar packages with only one code written on them. By the end of the study, none of the researchers and patients knew the contents of the drug capsules. 3 pre-diabetic condition. Intervention 1: Intervention group: Sugarheal medicinal composition from Samanik company: The amount of extract of each plant in one gram is calculated according to the amount of consumption of each plant per day. Therefore, in each gram of the extract, the weight of Capparis Spinosa extract 170 mg, Rosa canina 225 mg, Securigera securidaca170 mg, Silymarin 65 mg, Urtica dioica 170 mg, Trigonella foenum-graecum 115 mg and Vaccinium arctostaphylos 85 mg will be mixed together. 1000 mg of the extract mixture will be poured into two 500 mg long base capsules. The prepared capsule is packed in a box of 60 pieces. Patients will receive two doses from this medicine with their meals for 3 months and then second checkup will be done. Intervention 2: Control group: This group will receive metformin which is the standard protocol nowadays 500 mg twice a day with their meals for three months. These capsules are exactly as same as the capsules of intervention group. After 3 months the second checkup will be done. Yes - There is a plan to make this available What will be shared: the data would be sent without any personal information of patients When: after data gathering To whom: Only people with relevant permissions to use confidential information Conditions: The data can be used for statistical analysis and re-examination Where to obtain: mohamad heiat Phone no. +98 936 687 6929 How to obtain: After calling or sending an email, the data will be sent if the applicant is valid Comments:
public Mohammad heiat
mollasadra st. Vanak Tehran
تهران Iran (Islamic Republic of) 1435916471 +98 21 8755 5250 mohamad.heiat@gmail.com Bagheiat-allah University of Medical Sciences scientific Mohammad heyat
mollasadra st. Vanak Tehran
تهران Iran (Islamic Republic of) 1435916471 +98 21 8755 5250 mohamad.heiat@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) patients with confirmed prediabetic situation over 18 years old 18 years no limit Both patients with Chronic renal failure patients with Chronic liver failure patients with active pneumonia patients with Proliferative or active neoplastic retinopathy pregnancy or lactation History of allergy to herbal medicines Taking other drugs that affect blood sugar Treatment - Drugs Treatment - Drugs Intervention group: Sugarheal medicinal composition from Samanik company: The amount of extract of each plant in one gram is calculated according to the amount of consumption of each plant per day. Therefore, in each gram of the extract, the weight of Capparis Spinosa extract 170 mg, Rosa canina 225 mg, Securigera securidaca170 mg, Silymarin 65 mg, Urtica dioica 170 mg, Trigonella foenum-graecum 115 mg and Vaccinium arctostaphylos 85 mg will be mixed together. 1000 mg of the extract mixture will be poured into two 500 mg long base capsules. The prepared capsule is packed in a box of 60 pieces. Patients will receive two doses from this medicine with their meals for 3 months and then second checkup will be done. Control group: This group will receive metformin which is the standard protocol nowadays 500 mg twice a day with their meals for three months. These capsules are exactly as same as the capsules of intervention group. After 3 months the second checkup will be done. Fasting blood glucose change. Timepoint: 3 months. Method of measurement: blood test. Change in serum lipids(LDL, HDL, cholesterol, TG). Timepoint: 3 months. Method of measurement: blood test. Changes in insulin hormone level. Timepoint: 3 months. Method of measurement: blood test. Changes in blood BUN level. Timepoint: 3 months. Method of measurement: blood test. Changes in GTT test. Timepoint: 3 months. Method of measurement: blood test. Changes in Hb A1c level. Timepoint: 3 months. Method of measurement: blood test. Samanik company Approved 2022-05-21 Research Ethics Committees of Baqiyatallah Hospital mollasadra st. tehran Tehran Iran (Islamic Republic of)