NCT06413238

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

Investigating the Effects of Curcumin and Saffron on Fertility, Sugar, Lipid and Anthropometric Indicators in Women With Diabetes Mellitus of Reproductive Age

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fateme Moshirenia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

\## Study Hypotheses Summary: \*\*Primary Hypothesis:\*\* Women with diabetes mellitus receiving the intervention will exhibit significantly lower levels of sugar indicators (FBS, HA1c, 2HPP) and lipid indicators (LDL, HDL, TG) compared to the placebo group. \*\*Secondary Hypotheses:\*\* 1. \*\*Psychological Outcomes:\*\* The intervention group will show significant reductions in stress, anxiety, and depression compared to the placebo group. 2. \*\*Sexual Health Outcomes:\*\* The intervention group will experience improvements in sexual performance, marital satisfaction, and quality of sexual life compared to the placebo group. 3. \*\*Diabetes Management Outcomes:\*\* The intervention group will demonstrate improvements in clinical symptoms of diabetes and anthropometric index compared to the placebo group. 4. \*\*Medication Adherence:\*\* The intervention will be well-received by women with diabetes mellitus of reproductive age, leading to improved medication adherence.

Detailed description

The study is a four-arm trial testing the effectiveness of curcumin, saffron, and a combination of both compared to a placebo in women with diabetes. The trial will measure glucose and lipid levels, medication side effects, adherence to treatment, and various other health indicators at different time points. Participants will be recruited from a specialty diabetes clinic in Yazd province, Iran, with specific eligibility criteria including age, diabetes diagnosis, and exclusion criteria such as allergies and certain medication use. The diagnostic criteria for diabetes mellitus are outlined by the American Diabetes Association.

Conditions

• Women of Reproductive Age
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	curcumin, saffron, Combination of saffron and curcumin and placebo	This study investigates the individual and combined effects of curcumin and saffron on diabetes compared to a placebo group. It will assess the effects on both clinical and laboratory diabetes symptoms within and between groups. Participants will receive either two 500mg curcumin capsules in arm 1, one 15mg saffron capsule with a 500mg starch flour placebo in arm 2, one 500mg curcumin and one 15mg saffron capsule in arm 3, and two 500mg starch flour placebos in arm 4.

Timeline

• Start date: 2024-06-10
• Primary completion: 2024-12-01
• Completion: 2025-01-22
• First posted: 2024-05-14
• Last updated: 2024-05-21