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

NCT06413238 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: fatememoshirenia4420185791f.moshirenia40120262004
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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. 1.\*\*Psychological Outcomes:\*\* The intervention group will show significant reductions in stress, anxiety, and depression compared to the placebo group.
2. 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. 3.\*\*Diabetes Management Outcomes:\*\* The intervention group will demonstrate improvements in clinical symptoms of diabetes and anthropometric index compared to the placebo group.
4. 4.\*\*Medication Adherence:\*\* The intervention will be well-received by women with diabetes mellitus of reproductive age, leading to improved medication adherence.

Conditions

Women of Reproductive Age; Diabetes Mellitus

Keywords

diabetes; reproductive age; curcumin; saffron; lipid profile; sugar profile; enterometric indices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• stress, anxiety and depression

  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)

• marital satisfaction

  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)

Study Arms (4)

curcumin

OTHER

curcumin

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

saffron

OTHER

saffron

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

Combination

OTHER

Combination of saffron and curcumin

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

placebo

PLACEBO COMPARATOR

placebo

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

Interventions

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.

Combination; curcumin; placebo; saffron

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women with diabetes mellitus of reproductive age
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Fateme Moshirenia: lead
• Tarbiat Modarres University: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Central Study Contacts

fateme moshirenia, Master's degree

CONTACT

09135264607; f.moshirenia@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Midwifery & Reproductive Health, Medical Sciences Faculty, Tarbiat Modares University, Tehran, Iran

Model Details: 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

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 14, 2024
• Study Start: June 10, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 22, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF