Investigating the effects of curcumin and saffron on fertility, sugar, lipid and anthropometric indicators in women with diabetes mellitus of reproductive age

investigate the effectiveness of curcumin and saffron supplements in managing diabetes in women of reproductive age, considering both clinical and sexual health outcomes.

The present study will be a three-way blind clinical trial on 120 women of childbearing age with diabetes mellitus. Participants will be randomly divided into four groups. The four intervention groups will be as follows: group A (curcumin capsules = 30), group B (saffron capsules = 30), group C (combination of curcumin and saffron capsules = 30), and control group D (placebo = 30). The curcumin group will be administered two curcumin capsules daily, with a dose of 500 mg. The saffron group will be given one saffron capsule, with a dose of 15 mg, and a placebo capsule. The combined group will be given The curcumin group will be administered one curcumin capsule with a dose of 500 mg and one saffron capsule with a dose of 15 mg. The control group will be given two placebo capsules containing 500 mg of starch flour

The research focuses on diabetic women aged 18-45 registered in a specialized diabetes clinic in Yazd.

Anticoagulant use, pregnancy, breastfeeding, participants who had taken multivitamins or supplements affecting metabolism in the last three months were not included in the study, changes in diet and physical activity, experiencing a stressful event during the intervention ,and the use of drugs that affect sexual performance . Avoiding or excessively using these two ingredients)curcumin and saffron( in cooking (as per the research unit's findings)

Group1: two capsules of curcumin, group 2: one curcumin capsule and one saffron capsule, group 3: one saffron capsule and one placebo, and group 4 will receive two placebo capsules.

indicators (FBS, HA1c, 2HPP), as well as lipid indicators (LDL, HDL, TG).

We would like to inform you that there was a typo regarding age in the entry criteria section. In addition, according to the supervisor, the follow-up period has undergone some changes.

Block randomization method will be used to avoid significant imbalances in the number of participants assigned to each group, and block randomisation will ensure that there is no significant imbalance between groups at any point during randomisation. and at certain points the number of participants in each group will be equal. In this method, the size of each block is determined in this way. In this manner, each block will have two individuals from every four groups. There will be a total of 12 possibilities: AABBCC(1), ABBACC(2), ABBBBC(3), ABBCCC(4), ACBBCC(5), ABCCCD(6), ABBCCD(7), ACBBCC(8), ABBCD(9), ABBCD(10), ABBCD(11), and ABBCD(12). A list of available states will be prepared and numbered by the epidemiologist professor. The blocks will then be sorted based on random numbers from 1 to 12, from sealed envelopes, and numbered in order to use allocation concealment. The envelopes will be randomly selected by the researcher, and the research units will then be entered into the sampling system.

The capsules will be completely similar to each other in terms of shape, color and packaging, and after preparing the capsules, they will be kept next to each other for several days so that the smell of the capsules will merge and it will not be possible to identify the capsules through the smell. Packages of capsules containing curcumin and placebo, capsules containing curcumin and saffron, combined capsules containing saffron and placebo, and capsules containing two placebos will be named ABCD. The researcher and participants will not know how to code. And coding will be done by the pharmacist. Therefore, this intervention will be performed in a three-way blind method. Three-blind in the sense that the capsules will be prescribed without the researcher knowing about their contents, and the capsules will be consumed by the subjects without knowing about their contents, and the person analyzing the data will know which type of treatment each subject has received. will not have. The contents of the list will be destroyed after the end of sampling.