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IRCT20181006041252N7 IRCT 2019-01-25 Sabzevar University of Medical Sciences Investigating the effect of a supplement of hydroalcoholic extract of Eryngium on the metabolic marker in type 2 diabetic patients Investigating the effect of a supplement of hydroalcoholic extract of Eryngium on the metabolic marker in type 2 diabetic patients 2019-01-21 anticipated 84 Complete https://irct.ir/trial/36967 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was conducted based on a permutation block, Accordingly, 42 blocks were allocated to patients, in each block, 2 were from following groups, treatment group A and group B. Eventually, after completing the blocks, Group A and B were treated with hydroalcoholic extract of Eryngium and Placebo tablet, respectively, Blinding description: Each person will be assigned a study code A and B, which will only be known to the researcher of the type of groups. The clinical observant and the participants are unaware of the groups. It should be noted that hydroalcoholic extract of Eryngium and placebo have been similar in appearance, color, and packaging. 3 Type 2 diabetes. Intervention 1: Intervention group: Patients in this group are treated with Hydroalcoholic extract of Eryngium (10 drops 3 times a day) for 3 months. (Each ml (28 drops) of this drug contains 924 mg of dry Eryngium). Intervention 2: Control group: Patients in this group are treated with placebo (10 drops 3 times a day) for 3 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Dr. Fereshte Ghorat
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 8337 Drghorat@gmail.com Sabzevar University of Medical Sciences scientific Dr. Fereshte Ghorat
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 8337 Drghorat@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetes for at least 2 years HbA1C less than 8.5 Patients aged 20-60 years Non-insulin treated diabetic patients 20 years 60 years Both Pregnancy and breastfeeding Renal and cardiovascular disorders and chronic underlying disease Insulin therapy Micro and macro-vascular diabetic complications Use of other herbal medicines that have an effect on diabetes Smoking or alcohol abuse within a month before the study. E08 Diabetes mellitus due to underlying condition Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group are treated with Hydroalcoholic extract of Eryngium (10 drops 3 times a day) for 3 months. (Each ml (28 drops) of this drug contains 924 mg of dry Eryngium) Control group: Patients in this group are treated with placebo (10 drops 3 times a day) for 3 months. Determine Fasting Blood Sugar (FBS). Timepoint: At the beginning of the study (before the intervention) and 3 months after starting the intervention. Method of measurement: Use of Auto-Analyzer machine and Spectrophotometric method. Determination level of Glycosylated Hemoglobin (HbA1C). Timepoint: At the beginning of the study (before the intervention) and 3 months after starting the intervention. Method of measurement: Use of Auto-Analyzer machine and Spectrophotometric method. Determination level of Triglyceride. Timepoint: At the beginning of the study (before the intervention) and 3 months after starting the intervention. Method of measurement: Use of Auto-Analyzer machine and Spectrophotometric method. Determination level of Cholesterol. Timepoint: At the beginning of the study (before the intervention) and 3 months after starting the intervention. Method of measurement: Use of Auto-Analyzer machine and Spectrophotometric method. Determination level of Low-density Lipoprotein (LDL). Timepoint: At the beginning of the study (before the intervention) and 3 months after starting the intervention. Method of measurement: Use of Auto-Analyzer machine and Spectrophotometric method. Determination level of High-density Lipoprotein (HDL). Timepoint: At the beginning of the study (before the intervention) and 3 months after starting the intervention. Method of measurement: Use of Auto-Analyzer machine and Spectrophotometric method. Determination level of Creatinine. Timepoint: At the beginning of the study (before the intervention) and 3 months after starting the intervention. Method of measurement: Use of Auto-Analyzer machine and Spectrophotometric method. Determination level of Urea. Timepoint: At the beginning of the study (before the intervention) and 3 months after starting the intervention. Method of measurement: Use of Auto-Analyzer machine and Spectrophotometric method. Determination level of Alkaline Phosphatase. Timepoint: At the beginning of the study (before the intervention) and 3 months after starting the intervention. Method of measurement: Use of Auto-Analyzer machine and Spectrophotometric method. Determination level of Aspartate Aminotransferase (AST) (SGOT). Timepoint: At the beginning of the study (before the intervention) and 3 months after starting the intervention. Method of measurement: Use of Auto-Analyzer machine and Spectrophotometric method. Determination level of Alanine Aminotransferase (ALT) (SGPT). Timepoint: At the beginning of the study (before the intervention) and 3 months after starting the intervention. Method of measurement: Use of Auto-Analyzer machine and Spectrophotometric method. Sabzevar University of Medical Sciences Approved 2019-01-19 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city Sabzevar Razavi Khorasan Iran (Islamic Republic of)