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IRCT20130610013612N11 IRCT 2021-09-23 Tabriz University of Medical Sciences Effects of Fumaria Parviflora on diabetic patients The effect of Fumaria Parviflora hydro-alcoholic extract on lipid profile, blood glucose indices, inflammatory factors, oxidative stress indices, and liver enzymes in patients with type 2 diabetes under a low-calorie diet 2021-08-23 anticipated 66 Complete https://irct.ir/trial/58544 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the current study, we will apply block randomization, one type of restricted randomization. Blocking is usually used to make a balance in the number of assigned samples to each studies group. This characteristic helps researchers in assigning an equal number of samples to each group, in cases that middle analyses are needed during the sampling process. The size of all the blocks is equal and in this two-group experiment, we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Randomization tool also uses random allocation software that these random sequence generation software in addition to simple randomization are able to generate a random sequence by blocking method. For concealment, we use concealment allocation, which is the method used to execute a random sequence on study participants, so that the assigned group is not known before the individual is assigned. Using sealed opaque envelopes with random sequences (envelopes opaque, sealed, numbered sequentially) in which in this method each of the random sequences created is recorded on a card, and the cards inside the envelopes are placed in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of the participant is revealed, Blinding description: To reduce the bias or bias related to the intervention and the evaluation of outcomes, the double-blind method is used. In this way, the outcome can be measured objectively. In this method, the trial is planned in such a way that the participant and the researcher do not realize which of the two control or test groups they belong to. 3 Type 2 diabetic patients. Intervention 1: Intervention group: receives 550 mg daily of hydro-alcoholic extract of fumaria Parviflora for 2 months. Intervention 2: Control group: receive 550 mg daily of placebo consisting of cornstarch for 2 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr. Farzad Najafipour
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3335 7850 Farzadnajafipour@gmail.com Tabriz University of Medical Sciences scientific Dr. Frazad Najafipour
Imam Reza Hospital, Endocrinology and Metabolism Department
Tabriz Iran (Islamic Republic of) 5166614766 +98 914 107 8522 najafipourf@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients who agree to participate in the study Women aged 20 to 50 years (non-menopausal) and men 20 to 65 years BMI range between 25 and 40 kg /m2 ; Having type 2 diabetes for at least 6 months while taking blood sugar-lowering drugs (metformin and thiazolidine ) 20 years 65 years Both Reluctance to participate in the study Insulin injection Use any nutritional supplements such as omega-3 supplements or supplements that have anti-inflammatory and antioxidant properties in the past 3 months or during the study Liver and kidney failure and thyroid diseases Smoking and alcohol consumption Patients using NSAIDs, corticosteroids (prednisone, prednisolone, and hydrocortisone), thiazide (furosemide and hydrochlorothiazide), and second-generation antipsychotics (olanzapine and clozapine). Pregnancy and desire to conceive during the study Intestinal and gastrointestinal diseases and eating disorders E08 Diabetes mellitus due to underlying condition Treatment - Other Placebo Intervention group: receives 550 mg daily of hydro-alcoholic extract of fumaria Parviflora for 2 months Control group: receive 550 mg daily of placebo consisting of cornstarch for 2 months Total cholesterol. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test. Triglyceride. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test. High-density lipoprotein. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test. Low-density lipoprotein. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test. Atherogenic index of plasma. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test. Tumour Necrosis Factor alpha. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test. Interleukin 6. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test. Intercellular Adhesion Molecule 1‎. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test. Total antioxidant capacity. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood tests. Malondialdehyde. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood tests. Glutathione peroxidase. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood tests. Superoxide dismutase. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood tests. Catalase. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood tests. MCP-1gene expression. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Measurement of gene expression by RT-PCR method. Nf-kB gene expression. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Measurement of gene expression by RT-PCR method. BAX gene expression. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Measurement of gene expression by RT-PCR method. Nrf-2 gene expression. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Measurement of gene expression by RT-PCR method. BCL-2 gene expression. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Measurement of gene expression by RT-PCR method. Anthropometric indecs. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Body composition measuring device. Antropometric indices (Weight, Height, BMI, Waist circumference, Hip circumference, Waist to Hip Ratio). Timepoint: Baseline and 2 months after the intervention. Method of measurement: Physical exam. Tabriz University of Medical Sciences Approved 2021-07-26 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Daneshgah Sq. Tabriz East Azarbaijan Iran (Islamic Republic of)