The effect of saffron and vitamin E co-supplementation on glycemic control, hormonal, oxidative stress and disease symptom in women with polycystic ovary syndrome

Determining and comparing the average levels of glycemic, hormonal, oxidative stress, disease symptoms between the group receiving saffron extract and vitamin E supplement and the group receiving placebo and within each group before and after the intervention.

A clinical trial with a control group, with parallel groups, triple blind, randomized, phase 3 on 66 patients. SEALED ENVELOPE software was used for randomization.

In this study , patients with polycystic ovary syndrome ( pcos ) from patients referring to akbarabadi hospital under the coverage of iran university of medical sciences , whose disease has been confirmed by the doctor and have entry conditions will be selected and randomly assigned to one of the intervention and control groups. At the beginning and end of the trial, questionnaires and disease symptoms will be checked and blood samples will be taken from the participants early in the morning after a night of fasting, and the participants will not stop receiving standard treatment. The participant in the intervention group consumes a daily dose of 30 mg of saffron extract and 100 mg of vitamin E for 8 weeks, and the participants in the control group receive the same amount of placebo. Blinding is triple-blind, including the patient, the therapist, and the analyst.

Women with polycystic ovary syndrome in the age range of 18 to 45 and with BMI in the range of 25 to 35 are included in the study. Patients with a history of chronic diseases, taking glucose and weight reducing drugs, following a special diet do not participate in the study.

The intervention group consumes 30 mg of saffron extract and 100 mg of vitamins E daily for 8 weeks. The control group consumes the same amount of placebo or lactose.

Insulin, DHEA, hirsutism

Patients with entry requirements will be placed in groups A or B in order of reference based on the table of random numbers (in the simple randomization method derived from the sealed envelope computer program).They are assigned a number from 1 to 66. Then from the numbers 1 to 66, the number 33 is selected using the Random Number table, and the people in question are assigned to the drug A. The remaining 33 people then receive the drug B in such a way that people with a ratio of 1: 1 are randomly divided into two intervention and control groups, and the unit of randomization is individual. To conceal the allocation, same shape, same size, opaque, sealed and consecutively numbered medicine bottles will be used

This randomized triple-blinding clinical trial (in each clinical trial plan, three groups can affect the results of the study. these three groups are 1-research participants, 2-project executives, and 3-evaluators or those who analyze the data obtained. If blindness is done for all three groups involved in the study, it is called a three-blind study. It is. The study supplement (saffron extract and vitamin E) and Placebo have a very similar coating, color, smell, and each contains 60 capsules that are in a similar bottle and are given to Group A capsule A and Group B capsule code B based on the randomized list. It should be noted that the medicinal contents of each bottle are encoded on the bottles (Group A and Group B) by someone outside the research team (pharmaceutical company), and the research team is unaware of their interpretation.