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

Determination of the effect of hydro-alcoholic fumaria Parviflora extract on lipid profile, blood glucose indices, inflammatory factors, oxidative stress indices, in patients with type 2 diabetes under a low-calorie diet

The study will be performed as a double-blind randomized controlled clinical trial on 66 patients aged 2 to 6 years with type 2 diabetes. The RAS program is used for randomization.

This study will be performed on patients with type 2 diabetes in the age range of 20-65 years in the endocrinology department of Imam Reza Hospital in Tabriz.

inclusion criteria : 1.Patients who agree to participate 2.Women aged 20 to 50 years and men 20 to 65 years, 3.BMI range between 25 and 40 kg /m2, 4.Using blood-sugar-lowering drugs. Exclusion criteria : 1. Reluctance to participate in the study, 2.Insulin injection, 3.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, 4. Liver and kidney failure and thyroid disease, 5. Smoking and alcohol consumption, 6. Patients using NSAIDs, corticosteroids, thiazide, and second-generation antipsychotics, 7. Pregnancy and desire to conceive during the study, 8. Intestinal and gastrointestinal diseases and eating disorders

The intervention group will receive 550 mg hydroalcoholic extract of Fumaria parviflora once a day and one hour after breakfast, and the other group will receive 550 mg placebo capsules (cornstarch) one hour after breakfast.

Evaluation of the effect of hydro-alcoholic extract of fumaria Parviflora on lipid profile, blood glucose indices, inflammatory factors, oxidative stress indices, in patients with type 2 diabetes mellitus of a low-calorie diet,(BCL-2،Nrf-2،BAX، Nf-kB،MCP-1) gene expression

Adding new factors (gene expression)

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.

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.

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