This randomized controlled trial aims to evaluate the therapeutic effects of pure Ceylon cinnamon (Cinnamomum verum) supplementation combined with a structured self-efficacy-based educational program on glycemic control, lipid profiles, and neuropathic pain in adult patients with type 2 diabetes mellitus (T2DM) and painful diabetic peripheral neuropathy (PDPN). A total of 900 participants will be randomly assigned to three parallel arms: a standard care control group, a Ceylon cinnamon supplementation group (1,000 mg/day), and a combined intervention group (Ceylon cinnamon supplementation plus the self-efficacy educational program) over a 6-month period. The study hypothesizes that the combined approach will significantly improve glycemic parameters, reduce neuropathic pain severity, and enhance metabolic profiles compared to standard care alone.
Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 6 months.
Confirmed diagnosis of painful diabetic peripheral neuropathy (PDPN).
Age between 18 and 65 years.
Able to provide written informed consent and willing to comply with the study protocol, supplement intake, and educational sessions.
Type 1 diabetes mellitus or gestational diabetes.
Severe renal or hepatic impairment.
Known allergy, hypersensitivity, or contraindication to cinnamon or related botanical products.
Pregnancy or lactation.
Parallel
Ceylon Cinnamon (Cinnamomum verum) Supplement
Dietary supplementPure Ceylon cinnamon extract capsules (500 mg per capsule, taken twice daily, total dose 1,000 mg/day for 6 months).
Matching Placebo
Other interventionPlacebo capsules identical in appearance, color, and packaging to the cinnamon supplement, taken twice daily for 6 months
Self-Efficacy-Based Educational Program
BehavioralA structured educational program grounded in Bandura's social cognitive theory aimed at enhancing self-efficacy and self-management skills evaluated using the Diabetes Self-Efficacy Scale (DSES)in participants with diabetes
Change in Glycated Hemoglobin (HbA1c)
Evaluated from venous blood samples to assess glycemic control over the preceding 2 to 3 months, expressed as a percentage (%). Lower values indicate a better outcome (improved long-term glycemic control). Normal reference ranges typically fall below 5.7%, with diabetes management targets generally aiming for levels below 7.0%
Change in Fasting Blood Glucose (FBG)
Description: Evaluated from venous blood samples collected following an 8-hour overnight fast, measured in milligrams per deciliter (mg/dL). Lower values indicate a better outcome (improved fasting glycemic status).
Change in Lipid Profile Parameters
Evaluated from venous blood samples collected following an 8-hour overnight fast, measured in milligrams per deciliter (mg/dL). Directionality of improvement varies by component: Total Cholesterol: Lower values indicate a better outcome. Triglycerides: Lower values indicate a better outcome. Low-Density Lipoprotein Cholesterol (LDL-C): Lower values indicate a better outcome. High-Density Lipoprotein Cholesterol (HDL-C): Higher values indicate a better outcome.
Change in Neuropathic Pain Intensity
Evaluated using the Numerical Rating Scale (NRS). Participants rate their average neuropathic pain intensity over the preceding 7 days. Scores range from a minimum value of 0 (no pain) to a maximum value of 10 (worst possible pain). Higher scores indicate a worse outcome (greater pain intensity). Pain severity is categorized as mild (1-3), moderate (4-7), or severe (8-10).
Change in Diabetes Self-Efficacy Score
Evaluated using the Diabetes Self-Efficacy Scale (DSES). Item scores range from a minimum value of 1 (not at all confident) to a maximum value of 10 (totally confident), reported as an overall mean score (range 1-10). Higher scores indicate
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