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

No results posted yet for this study

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

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757399 on ClinicalTrials.gov