Investigating the Effects of Curcumin and Saffron on Fertility, Sugar, Lipid and Anthropometric Indicators in Women With Diabetes Mellitus of Reproductive Age
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Sugar and lipid indicators
研究概览
简要总结
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:**
- **Psychological Outcomes:** The intervention group will show significant reductions in stress, anxiety, and depression compared to the placebo group.
- **Sexual Health Outcomes:** The intervention group will experience improvements in sexual performance, marital satisfaction, and quality of sexual life compared to the placebo group.
- **Diabetes Management Outcomes:** The intervention group will demonstrate improvements in clinical symptoms of diabetes and anthropometric index compared to the placebo group.
- **Medication Adherence:** The intervention will be well-received by women with diabetes mellitus of reproductive age, leading to improved medication adherence.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Additionally, Absence of menorrhagia on the basis of the PBLAC chart
排除标准
- •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)
研究组 & 干预措施
curcumin
curcumin
干预措施: curcumin, saffron, Combination of saffron and curcumin and placebo (Drug)
saffron
saffron
干预措施: curcumin, saffron, Combination of saffron and curcumin and placebo (Drug)
Combination
Combination of saffron and curcumin
干预措施: curcumin, saffron, Combination of saffron and curcumin and placebo (Drug)
placebo
placebo
干预措施: curcumin, saffron, Combination of saffron and curcumin and placebo (Drug)
结局指标
主要结局
Sugar and lipid indicators
时间窗: 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.
次要结局
- stress, anxiety and depression(at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention))
- adherence to treatment(at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention))
- marital satisfaction(at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention))
- Sexual performance(at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention))
- quality of sexual(at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention))
研究者
Fateme Moshirenia
Department of Midwifery & Reproductive Health, Medical Sciences Faculty, Tarbiat Modares University, Tehran, Iran
Tarbiat Modarres University