Rationale and Design of Diabetes Management With Curcumin and Saffron (DMCS): a Randomised, Three Blind -Blind, Placebo-controlled Study
- Conditions
- Women of Reproductive AgeDiabetes Mellitus
- Interventions
- Drug: curcumin, saffron, Combination of saffron and curcumin and placebo
- Registration Number
- NCT06413238
- Lead Sponsor
- Fateme Moshirenia
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 120
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description curcumin curcumin, saffron, Combination of saffron and curcumin and placebo curcumin saffron curcumin, saffron, Combination of saffron and curcumin and placebo saffron Combination curcumin, saffron, Combination of saffron and curcumin and placebo Combination of saffron and curcumin placebo curcumin, saffron, Combination of saffron and curcumin and placebo placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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