About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ceylon Cinnamon (Cinnamomum verum) Supplement
- Matching Placebo
- Self-Efficacy-Based Educational Program