Rationale and Design of Diabetes Management With Curcumin and Saffron (DMCS): a Randomised, Three Blind -Blind, Placebo-controlled Study

Launched by FATEME MOSHIRENIA · May 9, 2024

Keywords

ClinConnect Summary

The Diabetes Management With Curcumin and Saffron (DMCS) trial is studying the effects of curcumin and saffron on women with type 2 diabetes. The main goal is to see if these natural ingredients can help lower blood sugar and cholesterol levels compared to a placebo (a substance with no active ingredients). In addition to blood sugar control, the study will also look at whether participants experience less stress, anxiety, and depression, as well as improvements in sexual health and adherence to their diabetes medications.

To participate, women need to be between 18 and 45 years old, married, and have been diagnosed with type 2 diabetes for at least a year. They should not be dependent on insulin and should have a healthy body weight. However, women who are allergic to turmeric or saffron, pregnant, breastfeeding, or taking certain medications will not be eligible. Participants can expect to receive either the curcumin and saffron intervention or a placebo, and their health will be monitored throughout the study to assess any changes in their diabetes management and overall well-being.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • being married, having type 2 diabetes(according to American Diabetes Association provides guidelines) that had been diagnosed and treated for at least one year, not being dependent on insulin, being between the ages of 18-45 and having a body mass index between 18.5 and 30. Additionally, Absence of menorrhagia on the basis of the PBLAC chart
• Exclusion Criteria:
• • Participants who are allergic to turmeric or saffron plant essence will be excluded from the study. Additionally, women who do not regularly use supplements or take drugs for at least 7 consecutive days per month were excluded. Anticoagulant use, pregnancy, and breastfeeding will be also exclusion criteria. Finally, participants who had taken multivitamins or supplements affecting metabolism in the last three months will be not included in the study. Exclusion criteria for the study will include changes in diet and physical activity, experiencing a stressful event during the intervention (as reported by the research unit), and the use of drugs that affect sexual performance (as reported by the research unit)