Rationale and Design of Diabetes Management With Curcumin and Saffron (DMCS): a Randomised, Three Blind -Blind, Placebo-controlled Study
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.
Timeline
- Start
- 2024-06-10
- Primary completion
- 2024-12-01
- Completion
- 2025-01-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Curcumin | Small molecule | 500 mg | — |
| Subject | Saffron | Traditional medicine (herbal / TCM) | 15 mg | — |