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IRCT20230313057707N1 IRCT 2023-05-04 Kian Pharmed Parsian "Effect of Nettles in treatment of diabetes" Evaluation of the Urtica Dioica effect on blood glucose parameters and lipidprofile in patients with type 2 diabetes: a randomized double-blind clinical trial 2023-07-23 anticipated 106 Complete https://irct.ir/trial/69147 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly assign people to two groups and ensure the balance of the number of people in the groups, the block randomization method will be used. In this study, blocks with sizes of four will be created and randomly half of The people of each block will be placed in one group and half in another group It is possible that half of the people will be assigned to group A (drug receiving group) and the other half will be assigned to group B (control group): 1-BAAB-6 ABBA-5 BABA-4 ABAB-3 BBAA-2 AABB Then, one of the numbers 1 to 6 will be assigned to each of the blocks of 4, and from blocks 1 to 6, simple random combinations (blocks) are made using the table of random numbers. Selection of blocks will continue until the division of 106 patients into two groups of 53 intervention and control. The selected blocks are written in a consecutive sequence and according to this sequence, the people included in the study will be assigned to one of two groups A or B. First sequence The results obtained are recorded using the block randomization method and a number from 1 to 106 will be assigned to each of the letters A and B in the created sequence, which indicates receiving the drug. Due to the unpredictability of the sequence created by the block randomization method, all researchers except the main researcher will remain unaware of the size and order of the blocks, Blinding description: Conducting this research is such that neither patients nor clinical caregivers know information that may affect the results. After giving the patient's number, the clinical caregivers deliver the package prepared for his number to the patient without knowing its content, and the patient does not know whether the delivered package is a medicine or a placebo. The packages have already been prepared by the researcher. and numbered. 3 Type 2 Diabetes. Intervention 1: Intervention group: The nettle group will receive 2 capsules of 250 mg, which will contain 25 mg of the active substance of nettle along with fillers, every 12 hours for 3 months. The status of medication use will be followed up by the researcher once a week through a phone call. A contact number will be provided to the patients to contact the researcher in case of any complications or other problems. In case of complications such as hypoglycemia or ketoacidosis, the drugs will be stopped and the patient will be evaluated and treated if necessary and excluded from the study.People will be told to bring the envelopes containing the drugs with them in any case (whether in case of complete use or in case of incomplete use) in the face-to-face examination at the end of the clinical trial for each patient. Clinical trials of patients up to 3 months after The start of treatment is monitored. The results of the tests are recorded in the questionnaire. Intervention 2: Control group: The placebo group will receive 2 capsules similar to nettle capsules that only contain fillers every 12 hours for 3 months.The status of medication use will be followed up by the researcher once a week through a phone call. A contact number will be provided to the patients to contact the researcher in case of any complications or other problems. In case of complications such as hypoglycemia or ketoacidosis, the drugs will be stopped and the patient will be evaluated and treated if necessary and excluded from the study.People will be told to bring the envelopes containing the drugs with them in any case (whether in case of complete use or in case of incomplete use) in the face-to-face examination at the end of the clinical trial for each patient. Clinical trials of patients up to 3 months after The start of treatment is monitored. The results of the tests are recorded in the questionnaire. 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 Ali Khosravi
Flat No. 3, 2nd floor, No. 8, Hamedan St., North Kargar Ave., Tehran., Iran
Tehran Iran (Islamic Republic of) 1418693884 +98 21 6694 4081 elhamfaghani69@yahoo.com Kian Pharmed Parsian scientific Ali Khosravi
Flat No. 3, 2nd floor, No. 8, Hamedan St., North Kargar Ave., Tehran., Iran
Tehran Iran (Islamic Republic of) 1418693884 +98 25 6694 4081 elhamfaghani69@yahoo.com Kian Pharmed Parsian Iran (Islamic Republic of) Having diabetes type 2 30 years 65 years Both Allergy E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: The nettle group will receive 2 capsules of 250 mg, which will contain 25 mg of the active substance of nettle along with fillers, every 12 hours for 3 months. The status of medication use will be followed up by the researcher once a week through a phone call. A contact number will be provided to the patients to contact the researcher in case of any complications or other problems. In case of complications such as hypoglycemia or ketoacidosis, the drugs will be stopped and the patient will be evaluated and treated if necessary and excluded from the study.People will be told to bring the envelopes containing the drugs with them in any case (whether in case of complete use or in case of incomplete use) in the face-to-face examination at the end of the clinical trial for each patient. Clinical trials of patients up to 3 months after The start of treatment is monitored. The results of the tests are recorded in the questionnaire. Control group: The placebo group will receive 2 capsules similar to nettle capsules that only contain fillers every 12 hours for 3 months.The status of medication use will be followed up by the researcher once a week through a phone call. A contact number will be provided to the patients to contact the researcher in case of any complications or other problems. In case of complications such as hypoglycemia or ketoacidosis, the drugs will be stopped and the patient will be evaluated and treated if necessary and excluded from the study.People will be told to bring the envelopes containing the drugs with them in any case (whether in case of complete use or in case of incomplete use) in the face-to-face examination at the end of the clinical trial for each patient. Clinical trials of patients up to 3 months after The start of treatment is monitored. The results of the tests are recorded in the questionnaire. The percentage of people who have a fasting blood sugar level above 120 mg/dl. Timepoint: Blood test before starting the drug and three months later (after taking the drug completely). Method of measurement: Fasting blood sugar test. HbA1C. Timepoint: Blood test before starting the drug and three months later (after taking the drug completely). Method of measurement: HbA1C test. Creatinine. Timepoint: Blood test before starting the drug and three months later (after taking the drug completely). Method of measurement: Creatinine test. Fasting insulin. Timepoint: Blood test before starting the drug and three months later (after taking the drug completely). Method of measurement: Fasting insulin test. Cholesterol. Timepoint: Blood test before starting the drug and three months later (after taking the drug completely). Method of measurement: Cholesterol test. Triglyceride. Timepoint: Blood test before starting the drug and three months later (after taking the drug completely). Method of measurement: Triglyceride test. Kian Pharmed Parsian Approved 2022-04-10 Reasearch Ethics Commitees of Endocrine & Metabolism Research Institute - Tehran University of Medic Tehran University of Medical Sciences Headquarters, Qods Corner, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)