Women of Reproductive AgePhase 1/2NCT06413238
Rationale and Design of Diabetes Management With Curcumin and Saffron (DMCS): a Randomised, Three Blind -Blind, Placebo-controlled Study
A Phase 1/2 study of Women of Reproductive Age and Diabetes Mellitus, run by Fateme Moshirenia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Women of Reproductive Age, Diabetes Mellitus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2024to 22 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this 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
## 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.
Read more
Secondary Hypotheses:
- Psychological Outcomes: The intervention group will show significant reductions in stress, anxiety, and depression compared to the placebo group.
- Sexual Health Outcomes: The intervention group will experience improvements in sexual performance, marital satisfaction, and quality of sexual life compared to the placebo group.
- Diabetes Management Outcomes: The intervention group will demonstrate improvements in clinical symptoms of diabetes and anthropometric index compared to the placebo group.
- Medication Adherence: The intervention will be well-received by women with diabetes mellitus of reproductive age, leading to improved medication adherence.
Read the 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
- Women of Reproductive Age, Diabetes Mellitus
- Being tested
- curcumin, saffron, Combination of saffron and curcumin and placebo
- Keywords
- diabetes, reproductive age, curcumin, saffron, lipid profile, sugar profile, enterometric indices
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcumin, saffron, Combination of saffron and curcumin and placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| curcumin | Other | curcumin Receives: Drug: curcumin, saffron, Combination of saffron and curcumin and placebo |
| saffron | Other | saffron Receives: Drug: curcumin, saffron, Combination of saffron and curcumin and placebo |
| Combination | Other | Combination of saffron and curcumin Receives: Drug: curcumin, saffron, Combination of saffron and curcumin and placebo |
| placebo | Placebo comparator | placebo Receives: Drug: curcumin, saffron, Combination of saffron and curcumin and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Sugar and lipid indicators will be measured at baseline Post-intervention .
Secondary outcomes (5)
stress, anxiety and depression
stress, anxiety, and depression will be measured by DASS21 questionnaire
Measured: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
Sexual performance
Sexual performance will be FSFI questionnaire
Measured: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
quality of sexual
quality of sexual life will be measured by SQOL-F questionnaire
Measured: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
marital satisfaction
marital satisfaction will be measured by SQOL-F questionnaire
Measured: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
adherence to treatment
adherence to treatment will be measured by Morisky questionnaire
Measured: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start10 Jun 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion22 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women of Reproductive AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fateme Moshirenia
- Sponsor type
- University, hospital or other
- Collaborators
- Tarbiat Modarres University
- Responsible party
- Sponsor-investigator, Fateme Moshirenia, Tarbiat Modarres University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413238
- Sponsor's protocol ID
- fatememoshirenia4420185791
- Other IDs
- f.moshirenia40120262004
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: starting 6 months after publication
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Curcumin and Saffron on Fertility, Sugar, Lipid and Anthropometric Indicators in Women With Diabetes Mellitus of Reproductive Age
- ClinicalTrials.gov ID
- NCT06413238
- Acronym / sponsor ID
- fatememoshirenia4420185791
- Conditions
- Women of Reproductive Age, Diabetes Mellitus
- Keywords
- diabetes, reproductive age, curcumin, saffron, lipid profile, sugar profile, enterometric indices
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fateme MoshireniaUniversity, hospital or other
- Collaborators
- Tarbiat Modarres University
- Study start
- 10 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 22 Jan 2025 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
## 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:
- Psychological Outcomes: The intervention group will show significant reductions in stress, anxiety, and depression compared to the placebo group.
- Sexual Health Outcomes: The intervention group will experience improvements in sexual performance, marital satisfaction, and quality of sexual life compared to the placebo group.
- Diabetes Management Outcomes: The intervention group will demonstrate improvements in clinical symptoms of diabetes and anthropometric index compared to the placebo group.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| curcumin | Other | Drug: curcumin, saffron, Combination of saffron and curcumin and placebocurcumin |
| saffron | Other | Drug: curcumin, saffron, Combination of saffron and curcumin and placebosaffron |
| Combination | Other | Drug: curcumin, saffron, Combination of saffron and curcumin and placeboCombination of saffron and curcumin |
| placebo | Placebo comparator | Drug: curcumin, saffron, Combination of saffron and curcumin and placeboplacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curcumin, saffron, Combination of saffron and curcumin and placeboThis 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. | Drug | Combination, curcumin, placebo, saffron |
Primary outcome
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.
5 secondary outcomes
stress, anxiety and depression
Time frame: 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)
quality of sexual
Time frame: 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)
adherence to treatment
Time frame: at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: Yes. starting 6 months after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Women of Reproductive Age and Diabetes Mellitus, run by Fateme Moshirenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fateme moshirenia, Master's degree (09135264607, f.moshirenia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sugar and lipid indicators (time frame: Sugar and lipid indicators will be measured at baseline Post-intervention .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.