Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413238
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-05
Brief Title:
Rationale and Design of Diabetes Management With Curcumin and Saffron DMCS a Randomised Three Blind -Blind Placebo-controlled Study
Sponsor:
Fateme Moshirenia
Organization:
Tarbiat Modarres University
Study Overview
Official Title:
Investigating the Effects of Curcumin and Saffron on Fertility Sugar Lipid and Anthropometric Indicators in Women With Diabetes Mellitus of Reproductive Age
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| fmoshirenia40120262004 | REGISTRY | curcuminsaffaron | None |