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

May 18, 2024 updated by: Fateme Moshirenia

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

## 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
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.
Other Names:
  • A,B,C.D
Other: curcumin
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.
Other Names:
  • A,B,C.D
Other: saffron
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.
Other Names:
  • A,B,C.D
Other: Combination
Combination of saffron and curcumin
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.
Other Names:
  • A,B,C.D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sugar and lipid indicators
Time Frame: Sugar and lipid indicators will be measured at baseline Post-intervention .
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
stress, anxiety and depression
Time Frame: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
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
Time Frame: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
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
Time Frame: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
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
Time Frame: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
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
Time Frame: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fateme Moshirenia

Collaborators

Tarbiat Modarres University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 22, 2025

Study Registration Dates

First Submitted

May 5, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 18, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fatememoshirenia4420185791
  • f.moshirenia40120262004 (Registry Identifier: curcuminsaffaron)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

starting 6 months after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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