Clinical trial NCT06413238: Rationale and Design of Diabetes Management With Curcumin and Saffron (DMCS): a Randomised, Three Blind -Blind, Placebo-controlled Study
Official title: Investigating the Effects of Curcumin and Saffron on Fertility, Sugar, Lipid and Anthropometric Indicators in Women With Diabetes Mellitus of Reproductive Age
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Women of Reproductive Age
Diabetes Mellitus
Keywords: diabetes
reproductive age
curcumin
saffron
lipid profile
sugar profile
enterometric indices
Lead sponsor: Tarbiat Modarres University
Sponsor class: OTHER
Collaborators: name: Tarbiat Modarres University
First posted: 2024-05-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In Arm curcumin, participants will receive two curcumin capsules, each with a dose of 500 mg, in addition to routine treatments. In Arm saffaron, participants will use one 15 mg saffron capsule and one placebo capsule, in addition to routine treatments. In Arm combination, participants will use one 500 mg curcumin capsule and one 15 mg saffron capsule, in addition to routine treatments. In Arm plasebo , participants will use two placebo capsules (500 mg starch flour), in addition to routine treatments
Primary purpose: TREATMENT

Brief 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.

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)

Primary outcomes:
measure: Sugar and lipid indicators
timeFrame: Sugar and lipid indicators will be measured at baseline Post-intervention .
Secondary outcomes:
measure: stress, anxiety and depression
timeFrame: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
measure: Sexual performance
timeFrame: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
measure: quality of sexual
timeFrame: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
measure: marital satisfaction
timeFrame: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
measure: adherence to treatment
timeFrame: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
Other outcomes:
Locations:
Study officials:
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