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IRCT20210724051965N1 IRCT 2022-01-18 Mazandaran University of Medical Sciences The effect of klatin capsule on type 2 diabetes Evaluation of the effect of herbal klatin capsule on laboratory indices and quality of life in type 2 diabetes patients 2022-02-19 anticipated 66 Complete https://irct.ir/trial/57693 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals will be randomly assigned to experimental and control groups using the size 4 random block method. For random assignment, each group will be considered as 4 people in 4 modes and therefore 6 different modes can occur: AABB-ABAB-ABBA-BAAB-BABA-BBAA. The number of people in each group is equal and this is repeated for 66 patients. According to the above block, 66 envelopes are prepared and A or B are placed in each envelope and numbers 1 to 66 are written on the envelopes. Someone outside the research team puts the letters A and B in the envelopes. A or B each represent the intervention or control group, which determines the type of intervention and A or B being a statistician, Blinding description: The drugs will be given in coded envelops. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind. 3 Type 2 diabetes mellitus. Intervention 1: Intervention group:In this group patients take their oral diabetes medications without any changes and in addition, they received klatin capsule (Contains 1000 mg of klatin plant extract of Plasma Darman Sarve Sepid Company) three times a day for 60 days. Intervention 2: Control group (placebo): In this group patients take their oral diabetes medications without any changes and in addition, they receive placebo (capsule containing 1000 mg microcrystalline cellulose of Plasma Darman Sarve Sepid Company) three times a day for 60 days. 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 It is not yet known if there will be a plan to make this available
public Sedighe Yousefi
Khazar Blvd., Khazar square
Sari Iran (Islamic Republic of) 48168-95475 +98 11 3324 4893 s.yousefi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Sedighe Yousefi
Touba clinic , Khazar Blvd., Khazar square
Sari Iran (Islamic Republic of) 48168-95475 +98 11 3324 4893 s.yousefi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having type 2 diabetes at least three months before enrollment Adults over 18 years 18 years no limit Both Pregnancy lactation kidney disease liver disease E11.9 Type 2 diabetes mellitus without complications Treatment - Drugs Placebo Intervention group:In this group patients take their oral diabetes medications without any changes and in addition, they received klatin capsule (Contains 1000 mg of klatin plant extract of Plasma Darman Sarve Sepid Company) three times a day for 60 days. Control group (placebo): In this group patients take their oral diabetes medications without any changes and in addition, they receive placebo (capsule containing 1000 mg microcrystalline cellulose of Plasma Darman Sarve Sepid Company) three times a day for 60 days. Fating blood sugar. Timepoint: At the beginning of the study (before the intervention) and 60 days after intervention. Method of measurement: Biochemistry- Glucose oxidase (enzymatic method). Hemoglobin A1c. Timepoint: At the beginning of the study (before the intervention) and 60 days after intervention. Method of measurement: Biochemistry- Calorimetry. Cholesterol. Timepoint: At the beginning of the study (before the intervention) and 60 days after intervention. Method of measurement: Calorimetric enzymatic. Triglyceride. Timepoint: At the beginning of the study (before the intervention) and 60 days after intervention. Method of measurement: Calorimetric enzymatic. Blood creatinine. Timepoint: Before the intervention and 60 days after the intervention. Method of measurement: Enzymatic. Blood urea nitrogen. Timepoint: Before the intervention and 60 days after the intervention. Method of measurement: Calorimetric enzymatic. Quality of Life. Timepoint: Before the intervention and 60 days after the intervention. Method of measurement: Quality of Life Assessment Questionnaire 15 questions for patients with diabetes. Mazandaran University of Medical Sciences Approved 2021-11-03 Research Ethics Committee of Mazandaran University of Medical Sciences Moallem square, Moallem avenue Sari Mazandaran Iran (Islamic Republic of)