## Protocol Section
### Identification Module
**NCT ID:** NCT06413238

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

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

#### Organization Study ID Info
**ID:** fatememoshirenia4420185791
#### Organization
**Class:** OTHER
**Full Name:** Tarbiat Modarres University
#### Secondary ID Infos
**Domain:** curcuminsaffaron
**ID:** f.moshirenia40120262004
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2025-01-22

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-18

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-05
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Tarbiat Modarres University

#### Lead Sponsor

**Class:** OTHER

**Name:** Fateme Moshirenia

#### Responsible Party

**Investigator Affiliation:** Tarbiat Modarres University

**Investigator Full Name:** Fateme Moshirenia

**Investigator Title:** Department of Midwifery & Reproductive Health, Medical Sciences Faculty, Tarbiat Modares University, Tehran, Iran

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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. \*\*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.

**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.

### Conditions Module

**Conditions:**

- Women of Reproductive Age

- Diabetes Mellitus

**Keywords:**

- diabetes

- reproductive age

- curcumin

- saffron

- lipid profile

- sugar profile

- enterometric indices

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 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

##### Masking Info

**Masking:** QUADRUPLE

**Masking Description:** 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.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** curcumin

**Intervention Names:**

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

**Label:** curcumin

**Type:** OTHER

#### Arm Group 2

**Description:** saffron

**Intervention Names:**

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

**Label:** saffron

**Type:** OTHER

#### Arm Group 3

**Description:** Combination of saffron and curcumin

**Intervention Names:**

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

**Label:** Combination

**Type:** OTHER

#### Arm Group 4

**Description:** placebo

**Intervention Names:**

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

**Label:** placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Combination

- curcumin

- placebo

- saffron

**Description:** 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.

**Name:** curcumin, saffron, Combination of saffron and curcumin and placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Sugar and lipid indicators

**Time Frame:** Sugar and lipid indicators will be measured at baseline Post-intervention .

#### Secondary Outcomes

**Description:** stress, anxiety, and depression will be measured by DASS21 questionnaire

**Measure:** stress, anxiety and depression

**Time Frame:** at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)

**Description:** Sexual performance will be FSFI questionnaire

**Measure:** Sexual performance

**Time Frame:** at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)

**Description:** quality of sexual life will be measured by SQOL-F questionnaire

**Measure:** quality of sexual

**Time Frame:** at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)

**Description:** marital satisfaction will be measured by SQOL-F questionnaire

**Measure:** marital satisfaction

**Time Frame:** at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)

**Description:** adherence to treatment will be measured by Morisky questionnaire

**Measure:** adherence to treatment

**Time Frame:** at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)

### Eligibility Module

**Eligibility Criteria:** 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)

**Gender Based:** True

**Gender Description:** women with diabetes mellitus of reproductive age

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** f.moshirenia@gmail.com

**Name:** fateme moshirenia, Master's degree

**Phone:** 09135264607

**Role:** CONTACT

### IPD Sharing Statement Module

**Description:** starting 6 months after publication

**Info Types:**

- STUDY_PROTOCOL

- ICF

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6685

- Name: Curcumin

- Relevance: HIGH

- As Found: Prevalence

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003474

- Term: Curcumin

### Misc Info Module

- Version Holder: 2024-05-31
