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IRCT20190728044350N1 IRCT 2019-09-08 Rasht University of Medical Sciences "'Effect of Diabetosit herbal supplement in treatment of Diabetes" The effect of diabetosit supplement (extract of nettle leaf and olive leaf) on blood glucose and lipid profile in type 2 diabetic patients 2019-10-07 anticipated 30 Complete https://irct.ir/trial/41128 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients who have medical records in the clinic and hospital and eligible for participating in the study are numbered and then a random number will be found by using the" Randomizer Research" software. This number is multiply by the number of samples(30). This process is repeated to reach the total sample size in the study. We can make a block with two in one block (block size is two) with two possible sequences of AB to assign sample numbers equally to each group. Above the consent form of the participants are labeled letters A or B in each group (n = 30) and these forms are provided to the secretaries of clinics. An independent nurse prepares syrups with “drug A” and “drug B” and put them into boxes according to the allocation orders. These syrups cannot be distinguished because they contain the same colored liquid with the same volume. Syrups will be given to them after the consent is signed based on the letter mentioned above the form by clinic nurse. Secretaries, clinical caregivers and nurses have no information about the type of syrups, Blinding description: Main medication and placebo are coded in order to be double-blind. Clinical providers,clinicians and patients are unaware of the type of drug being offered. Both of case and control groups,will receive placebo or herbal oral solution as 20 ml pre-meal for 8 weeks in addition to the usual treatment. . Only in analyzing data each group will be identified. 3 Type 2 diabetes mellitus. Intervention 1: Receiving herbal supplement Diabetosit made by Yasin Teb Gostar Co for 8 weeks, 20 cc, three times a day before meals. Ingredients of 1 Liter Diabetosit ُSupplement : 100 grams of dried nettle leaves extract and 100 grams of dried olive leaves extract in 1 liter olive oil. Intervention 2: Control group:will receive the usual treatment in addition to a solution similar to diabetosit ( new supplement) as the placebo. Yes - There is a plan to make this available What will be shared: All data is shared anonymous. When: 6 months after publishing the results To whom: Academic researchers, pharmacists, and industry leaders Conditions: Analysis of side effects Where to obtain: Zahra Mohtasham-Amiri, P.O Box 3381 Rasht, Iran mohtashamaz@yahoo.com How to obtain: The letter should state the reason and usage for the request.It will be answered as soon as possible. Comments:
public Zahra Mohtasham-Amiri
Poursina Hospital, Parastar Ave,Namjoo St,
Rasht Iran (Islamic Republic of) 4163545851 +98 13 3336 8773 mohtashamaz@yahoo.com Rasht University of Medical Sciences scientific Zahra Mohtasham-Amiri
No , Nasim Abv, Deilaman Blvd, Golsar St
Rasht Iran (Islamic Republic of) 4163545851 +98 13 3375 9480 zmamiri2000@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Over 30 years old Under treatment with oral glucose-lowering drugs 30 years no limit Both Insulin dependent patients History of heart disease or myocardial infarction History of asthma and allergy to nettle Hepatic insufficiency Pregnancy or lactation Thyroid diseases Severe infection Renal Insufficiency E11 Type 2 diabetes mellitus Treatment - Other Placebo Receiving herbal supplement Diabetosit made by Yasin Teb Gostar Co for 8 weeks, 20 cc, three times a day before meals. Ingredients of 1 Liter Diabetosit ُSupplement : 100 grams of dried nettle leaves extract and 100 grams of dried olive leaves extract in 1 liter olive oil. Control group:will receive the usual treatment in addition to a solution similar to diabetosit ( new supplement) as the placebo. Percentage of patients with Fasting blood sugar lower than 140 mg/dl. Timepoint: At baseline and 8 weeks after study. Method of measurement: Biochemical tests are carried out by the Selectra autoanalyser. Total cholesterol will be measured enzymatically using cholesterol esterase and cholesterol oxidase. HDL-C is measured after deposition of lipoproteins containing APO-B by phosphotungstic acid with the same enzymatic method of total cholesterol. Triglycerides will be carried out enzymatically using glycerol phosphate oxidase. LDL-C is measured in serum samples with triglyceride levels equal or less than 400 mg / dl using the Freidwald formula. Blood pressure. Timepoint: At baseline and 8 weeks after. Method of measurement: Using mercury sphygmomanometer. Yasin Sina-Gostar Approved 2019-06-26 Ethics committee of Guilan University of Medical Sciences No 8, Nasim Ave, Deilaman Blvd, Golsar, Rasht Rasht Guilan Iran (Islamic Republic of)