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This study will evaluate the effects of Rosmarinus officinalis (rosemary) extract on oxidative stress and inflammation in patients with type 2 diabetes. Participants will be randomly assigned to receive either rosemary extract or a placebo for 12 weeks. The study aims to determine whether rosemary extract can improve health markers related to oxidative stress, inflammation, and metabolic function.
This randomized, placebo-controlled clinical trial aims to evaluate the effects of Rosmarinus officinalis extract on oxidative stress, inflammation, and metabolic parameters in patients with type 2 diabetes. Participants will be randomly assigned to receive either rosemary extract or placebo for a duration of 12 weeks.
Primary outcomes include changes in oxidative stress biomarkers such as malondialdehyde (MDA), antioxidant enzyme activity including superoxide dismutase (SOD), and glutathione (GSH) levels. Secondary outcomes include inflammatory markers such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), as well as metabolic parameters, liver function tests, and renal function biomarkers.
This study seeks to provide scientific evidence on the potential role of Rosmarinus officinalis as a complementary therapeutic strategy to reduce oxidative stress and inflammation in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (control group) | Placebo Comparator | Participants will receive a placebo for 12 weeks. |
|
| Rosemary extract | Experimental | Methanolic extract of Rosmarinus officinalis administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Inactive substance with no therapeutic effect. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in levels of Glutathione | Evaluation of reduced glutathione concentration as an indicator of antioxidant status. (µmol/L) | .Baseline (Day 0) and Month 3 |
| Change in serum levels of Malondialdehyde | Measurement of serum malondialdehyde concentration as a marker of lipid peroxidation and oxidative stress. Change in serum malondialdehyde (MDA) levels (nmol/mL) | Baseline (Day 0), Month 1, Month 2, Month 3 |
| Change in antioxidant enzyme activity of Superoxide Dismutase | Assessment of superoxide dismutase activity in serum samples. Change in superoxide dismutase (SOD) activity (U/mL) | Baseline (Day 0) and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum levels of Interleukin-6 | Quantification of IL-6 levels using immunoassay techniques. Change in serum interleukin-6 (IL-6) levels (pg/mL) | Baseline (Day 0) and Month 3 |
| Change in serum levels of Tumor Necrosis Factor Alpha |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change in glycated hemoglobin (HbA1c) (%) | Baseline (Day 0) and End of Intervention (Month 3) |
Inclusion Criteria:
Exclusion Criteria:
5. Patients who are participating in another clinical trial simultaneously.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISSSTE (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado) | Zacatecas City | Zacatecas | 98160 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Rodríguez, J. M., Lazalde Ramos, B. P., Galván Valencia, M., & Quirarte Báez, S. M. (2025). Propiedades Terapéuticas del Romero (Rosmarinus officinalis L.) en el Manejo de la Diabetes Mellitus 2, Perspectivas Metabólicas y Clínicas: Una Revisión Bibliográfica. Ciencia Latina Revista Científica Multidisciplinar, 9(3), 8630-8648. https://doi.org/10.37811/cl_rcm.v9i4.18494 | ||
| 31909576 | Background | Quirarte-Baez SM, Zamora-Perez AL, Reyes-Estrada CA, Gutierrez-Hernandez R, Sosa-Macias M, Galaviz-Hernandez C, Manriquez GGG, Lazalde-Ramos BP. A shortened treatment with rosemary tea (rosmarinus officinalis) instead of glucose in patients with diabetes mellitus type 2 (TSD). J Popul Ther Clin Pharmacol. 2019 Dec 3;26(4):e18-e28. doi: 10.15586/jptcp.v26i4.634. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 3, 2025 |
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Two parallel groups of 20 participants each. One group receives 500 mg of placebo (microcrystalline cellulose) daily, and the other group receives 500 mg of methanolic rosemary extract daily. The intervention lasts for 12 weeks
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Participants are blinded to treatment assignment. Both placebo (microcrystalline cellulose) and rosemary extract capsules are identical in appearance, packaging, and labeling, ensuring that participants cannot distinguish which intervention they receive.
| Rosmarinus officinalis extract |
| Dietary Supplement |
Methanolic extract of Rosmarinus officinalis administered orally for 12 weeks |
|
Evaluation of TNF-α as a marker of systemic inflammation. Change in serum tumor necrosis factor-alpha (TNF-α) levels (pg/mL)
| Baseline (Day 0) and Month 3 |
| Mar 23, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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