Rationale and design of Diabetes Management with curcumin and saffron (DMCS): a randomised, three blind -blind, placebo-controlled study

Phase 2

• Conditions: diabetes mellitus.; Diabetes mellitus(E10-E14); (E10-E14)

• Registration Number: IRCT20160809029281N4
• Lead Sponsor: Yazd University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Married Women of reproductive age with diabetes mellitus
Treated for at least one year
Not being dependent on insulin
Being between the ages of 18-45
Having a body mass index between 18.5 and 30.
Absence of menorrhagia on the basis of the PBLAC chart

Exclusion Criteria

Unwillingness to participate in the study, under insulin treatment

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sugar indicators (FBS, HA1c, 2HPP) and lipid indicators (LDL, HDL, TG). Timepoint: at baseline and Completion of the intervention. Method of measurement: will be measured using Delta DP diagnostic kits(31).

Secondary Outcome Measures

Name	Time	Method
Anthropometric index marital satisfaction ,stress, anxiety, depression ,quality of sexual life and sexual performance. Timepoint: At baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention. Method of measurement: Stress, anxiety, and depression using the DASS21 questionnaire Sexual performance will be assessed using the FSFI questionnaire , while marital satisfaction will be evaluated using the KMS questionnaire , Additionally, the quality of sexual life will be measured using the SQOL-F questionnaire . In addition, anthropometric index (BMI, Waistline and hips) , Waistline and hips will be calculated as weight (kilograms) divided by height(meters) squared.