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| ID | Type | Description | Link |
|---|---|---|---|
| f.moshirenia40120262004 | Registry Identifier | curcuminsaffaron |
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| Name | Class |
|---|---|
| Tarbiat Modarres University | OTHER |
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## 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:**
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| curcumin | Other | curcumin |
|
| saffron | Other | saffron |
|
| Combination | Other | Combination of saffron and curcumin |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| curcumin, saffron, Combination of saffron and curcumin and placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sugar and lipid indicators | 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. | Sugar and lipid indicators will be measured at baseline Post-intervention . |
| Measure | Description | Time Frame |
|---|---|---|
| stress, anxiety and depression | stress, anxiety, and depression will be measured by DASS21 questionnaire | at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) |
| Sexual performance |
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Inclusion Criteria:
Exclusion Criteria:
women with diabetes mellitus of reproductive age
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| fateme moshirenia, Master's degree | Contact | 09135264607 | f.moshirenia@gmail.com |
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starting 6 months after publication
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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
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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.
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Sexual performance will be FSFI questionnaire
| at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) |
| quality of sexual | quality of sexual life will be measured by SQOL-F questionnaire | at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) |
| marital satisfaction | marital satisfaction will be measured by SQOL-F questionnaire | at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) |
| adherence to treatment | adherence to treatment will be measured by Morisky questionnaire | at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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