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Rationale and Design of Diabetes Management With Curcumin and Saffron (DMCS): a Randomised, Three Blind -Blind, Placebo-controlled Study
Sponsor: Fateme Moshirenia
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.
Official title: Investigating the Effects of Curcumin and Saffron on Fertility, Sugar, Lipid and Anthropometric Indicators in Women With Diabetes Mellitus of Reproductive Age
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-06-10
Completion Date
2025-01-22
Last Updated
2024-05-21
Healthy Volunteers
No
Interventions
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.