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IRCT20210125050142N1 IRCT 2021-03-11 National institute for medical research development Evaluation the effect of fenugreek on reducing blood lipids Evaluation the effect of the fenugreek hydrolyzed protein on lipids and CRP levels in hypercholesterolemia patients 2021-04-04 anticipated 60 Complete https://irct.ir/trial/53920 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, it determines a total sample size, then randomly assigns a set of them to groups A and group B, which is executed by random allocation software, which produces a sequence of random numbers with the intended code. The output list of random numbers is printed. Then, based on the sample size of the research, a number of envelopes are prepared and each of the random sequences created is registered on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, one of the envelopes of the letter is opened and the assigned group of the participant is revealed according to the order of entry of the eligible participants, Blinding description: This study is double-blind. Both participants and outcome assessors are unaware of the type of intervention received, but patients will be explained how to implement the plan and whether they are randomly assigned to one of these two groups. The size, color and design of the drug under study and the placebo prescribed in the two groups are quite similar. The lead researcher determines the drug codes and the participants and evaluators of the project are not aware of the type of drugs received. 3 Hypercholesterolemia. Intervention 1: Intervention group: Patients in this group will be prescribed a 40 gram capsule of fenugreek hydrolyzed protein daily for 2 months. Lipid profile, hs-CRP level, fasting blood sugar, blood pressure and body mass index will be measured before the intervention and after 2 months of follow-up when the patient taking the prescribed drug. Intervention 2: Control group: Patients in this group will be prescribed a 40-gram placebo capsule, which is similar in appearance and packaging to the main drug under study, daily for 2 months. Lipid profile, hs-CRP level, fasting blood sugar, blood pressure and body mass index will be measured before the intervention and after 2 months of follow-up when the patient is taking the prescribed drug. 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 more information
public Mahdi Badiee Gavarti
School of Medicine; Isfahan University of Medical Sciences and Health Services; Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3577 0701 badiee9675@gmail.com Esfahan University of Medical Sciences scientific Masoumeh Sadeghi
Shahid Rahmani Alley., Salman-e-Farsi, Isfahan, Isfahan Province
Isfahan Iran (Islamic Republic of) 81661 73414 +98 31 3611 5310 sadeghimasoumeh@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with low to moderate risk for cardiovascular events LDL 116 -180 mg /dL 18 years 65 years Both Drinking alcohol, Use of effective supplements on blood lipids (such as fish oil), Immunosuppressive drugs, blood lipid-lowering drugs (statins, fibrates, niacin, …) People with hypothyroidism, nephrotic syndrome or renal dysfunction or liver dysfunction People with uncontrolled hypertension (systolic blood pressure greater than 160 or diastolic blood pressure greater than 100 mmHg), History of dizziness and convulsions, Pregnancy or lactation Sensitivity to studied plant Treatment - Drugs Placebo Intervention group: Patients in this group will be prescribed a 40 gram capsule of fenugreek hydrolyzed protein daily for 2 months. Lipid profile, hs-CRP level, fasting blood sugar, blood pressure and body mass index will be measured before the intervention and after 2 months of follow-up when the patient taking the prescribed drug. Control group: Patients in this group will be prescribed a 40-gram placebo capsule, which is similar in appearance and packaging to the main drug under study, daily for 2 months. Lipid profile, hs-CRP level, fasting blood sugar, blood pressure and body mass index will be measured before the intervention and after 2 months of follow-up when the patient is taking the prescribed drug. Mean of Total Cholesterol. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Blood level mg mg / dL by laboratory. Mean of High-Density Lipoprotein. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Blood level mg mg / dL by laboratory. Mean of Low-Density Lipoprotein. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Blood level mg mg / dL by laboratory. Mean of Triglyceride. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Blood level mg mg / dL by laboratory. Mean of high-sensitivity C-reactive protein. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Blood level mg mg / dL by laboratory. Mean of fasting blood sugar. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Blood level mg mg / dL by laboratory. Mean of blood pressure. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Blood pressure monitor. Mean of body mass index. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Tape meters, digital scales and calculation formulas. National institute for medical research development Approved 2020-01-14 ethics committee of the National Institute for medical research development No. 21, beginning of Besat St., West Fatemi St., Tehran Tehran Tehran Iran (Islamic Republic of)