The Therapeutic Effects of Ceylon Cinnamon Supplementation and a Self-Efficacy Educational Program on Glycemic Control, Lipid Profiles, and Pain in Type 2 Diabetes Mellitus With Painful Diabetic Peripheral Neuropathy
NCT07757399 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900
Last updated 2026-08-11
Summary
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.
Conditions
- Type 2 Diabetes Mellitus
- Painful Diabetic Peripheral Neuropathy (PDPN)
Interventions
- DIETARY_SUPPLEMENT
-
Ceylon Cinnamon (Cinnamomum verum) Supplement
Pure Ceylon cinnamon extract capsules (500 mg per capsule, taken twice daily, total dose 1,000 mg/day for 6 months).
- OTHER
-
Matching Placebo
Placebo capsules identical in appearance, color, and packaging to the cinnamon supplement, taken twice daily for 6 months
- BEHAVIORAL
-
Self-Efficacy-Based Educational Program
A 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
Sponsors & Collaborators
-
Jerash Private University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2026-12-01
- Completion
- 2026-12-01
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