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

Fateme Moshirenia

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Diabetes Mellitus; Women of Reproductive Age

Treatments: Drug: curcumin, saffron, Combination of saffron and curcumin and placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06413238

fatememoshirenia4420185791

f.moshirenia40120262004 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

curcumin

Other group

Description:

curcumin

Treatment:

Drug: curcumin, saffron, Combination of saffron and curcumin and placebo

saffron

Other group

Description:

saffron

Treatment:

Drug: curcumin, saffron, Combination of saffron and curcumin and placebo

Combination

Other group

Description:

Combination of saffron and curcumin

Treatment:

Drug: curcumin, saffron, Combination of saffron and curcumin and placebo

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: curcumin, saffron, Combination of saffron and curcumin and placebo