Rationale and Design of Diabetes Management With Curcumin and Saffron (DMCS): a Randomised, Three Blind -Blind, Placebo-controlled Study

Diabetes Mellitus Clinical Trial

Official title:

Investigating the Effects of Curcumin and Saffron on Fertility, Sugar, Lipid and Anthropometric Indicators in Women With Diabetes Mellitus of Reproductive Age

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06413238
• Other study ID #: fatememoshirenia4420185791
• Secondary ID: f.moshirenia4012
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 10, 2024
• Est. completion date: January 22, 2025

Study information

• Verified date: May 2024
• Source: Tarbiat Modarres University
• Contact: fateme moshirenia, Master's degree
• Phone: 09135264607
• Email: f.moshirenia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 22, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• curcumin, saffron, Combination of saffron and curcumin and placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fateme Moshirenia	Tarbiat Modarres University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .
Secondary	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)
Secondary	Sexual performance	Sexual performance will be FSFI questionnaire	at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
Secondary	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)
Secondary	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)
Secondary	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)