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IRCT20080901001157N15 IRCT 2019-08-01 Iranian academic center for education culture and research Effect of Silybum marianum, Melissa officinalis, Vaccinium arctostaphylos, Trigonella foenum, Urtica dioica, and Citrullus colocynthis extract mixture on blood sugar control in type 2 diabetic patients Effect of Silybum marianum, Melissa officinalis, Vaccinium arctostaphylos, Trigonella foenum, Urtica dioica, and Citrullus colocynthis extract mixture on blood sugar control in type 2 diabetic patients 2019-10-22 anticipated 60 Complete https://irct.ir/trial/40872 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a random number table and block randomization method is used. In this method the patients are assigned into blocks of 2 patients (total 30 blocks). Then, each of the 2 patients entered the block of herbal drug or placebo, with 30 patients assigned to each group. There is no significant difference in fasting blood glucose and glycosylated hemoglobin in each group, Blinding description: Package for herbal and placebo is labeled with code B or A. Other specifications on the labels are identical. Physicians, nurses, patients, data collectors and those who evaluate the outcome are unaware of the drug and placebo group. Only laboratory expert knows the types of the groups. Patients are aware that they are either in the herbal drug or placebo groups, but they are not aware of the type of group they are in. 2 Diabetes. Intervention 1: Intervention group: Patients in this group receive a 500 mg capsule of herbal drug twice a day after breakfast.The herbal drug capsule contains mixture of mentioned herbal extract powder and will be prepared in the pharmacognosy department of the Institute of Medicinal Plants, Jahad-e-daneshgahi. Intervention 2: Control group: Patients in this group receive a 500 mg capsule of placebo twice a day after breakfast.The placebo capsule contains toasted flour and will be prepared in the pharmacognosy department of the Institute of Medicinal Plants, Jahad-e-daneshgahi. 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 There is no further information
public Hasan Fallah Huseini
Institute of Medicinal Plants, Kavosh Blvd., Supa Blvd., Poleh Kordan
Tehran Iran (Islamic Republic of) 3365166571 +98 26 3476 4010 h.fallah@acecr.ac.ir Iranian academic center for education culture and research scientific Hasan Fallah Huseini
Institute of Medicinal Plants, Kavosh Blvd., Supa Blvd., Poleh Kordan
Tehran Iran (Islamic Republic of) 3365166571 +98 26 3476 4010 h.fallah@acecr.ac.ir Iranian academic center for education culture and research Iran (Islamic Republic of) Patients with mild to moderate type 2 diabetes 40 to 60 years old Have diabetes for at least two years Under treatment with a maximum daily dose of 1000 mg metformin and 10 mg glibenclamide Fasting blood glucose levels between 130 to 170 mg/dL Glycosylated hemoglobin between 7.5 to 8.5% 40 years 60 years Both Patients with diabetic foot ulcer, gangrene, or any severe illness Painful diabetic neuropathy and depressed patients Smokers and alcoholic patients Patients who tend to change their exercise program or diet E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: Patients in this group receive a 500 mg capsule of herbal drug twice a day after breakfast.The herbal drug capsule contains mixture of mentioned herbal extract powder and will be prepared in the pharmacognosy department of the Institute of Medicinal Plants, Jahad-e-daneshgahi. Control group: Patients in this group receive a 500 mg capsule of placebo twice a day after breakfast.The placebo capsule contains toasted flour and will be prepared in the pharmacognosy department of the Institute of Medicinal Plants, Jahad-e-daneshgahi. Fasting blood glucose. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood glucose level will be determined in laboratory by commercial standard kit. Glycosylated hemoglobin. Timepoint: At starting of the study and after 3 months. Method of measurement: Glycosylated hemoglobin will be determined in laboratory by commercial standard kit. Triglyceride. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood triglyceride level will be determined in laboratory by commercially available kit. Cholesterol. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood cholesterol level will be determined in laboratory by commercially available kit. Low-density lipoprotein. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood low-density lipoprotein level will be determined in laboratory by commercially available kit. High-density lipoprotein. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood High-density lipoprotein level will be determined in laboratory by commercially available kit. Aspartate aminotransferase. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood aspartate aminotransferase level will be determined in laboratory by commercially available kit. Alanine aminotransferase. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood alanine aminotransferase level will be determined in laboratory by commercially available kit. Blood urea nitrogen. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood blood urea nitrogen level will be determined in laboratory by commercially available kit. Creatinine. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood creatinine level will be determined in laboratory by commercially available kit. Alkalin phosphatase. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood Alkalin phosphatase level will be determined in laboratory by commercially available kit. Iranian academic center for education culture and research Approved 2019-07-02 Ethics Committee of Avicenna Research Institute Shahid Beheshti University, Tabnak Street, Shahid Chamran Highway, Evin, Tehran. IRAN Tehran Tehran Iran (Islamic Republic of)