Diabetes Mellitus, Women of Reproductive Age
Conditions
Keywords
diabetes, reproductive age, curcumin, saffron, lipid profile, sugar profile, enterometric indices
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.
Interventions
DRUGcurcumin, 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.
Sponsors
Tarbiat Modarres University
Fateme Moshirenia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study will involve capsules with different combinations of curcumin, saffron, and placebos, labeled as ABCD. The capsules will be identical in appearance and smell to maintain blinding. The researcher, participants, and pharmacist will be unaware of the capsule contents. This three-way blind method aims to eliminate bias in the study.
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sugar and lipid indicators | Sugar and lipid indicators will be measured at baseline Post-intervention . | Sugar and lipid indicators will be measured using Delta DP diagnostic kits. The Delta DP diagnostic kits have an inter-assay CV of \<3% and an intra-assay CV of \<2%, indicating highly accurate and reliable test results within the same assay and between different assays. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| stress, anxiety and depression | at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) | stress, anxiety, and depression will be measured by DASS21 questionnaire |
| Sexual performance | at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) | Sexual performance will be FSFI questionnaire |
| quality of sexual | at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) | quality of sexual life will be measured by SQOL-F questionnaire |
| marital satisfaction | at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) | marital satisfaction will be measured by SQOL-F questionnaire |
| adherence to treatment | at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) | adherence to treatment will be measured by Morisky questionnaire |
Contacts
Primary Contactfateme moshirenia, Master's degree
Outcome results
None listed