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
Ceylon-EDU-RCT
1 other identifier
interventional
900
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Aug 2026
Shorter than P25 for not_applicable type-2-diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedFirst Posted
Study publicly available on registry
August 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
August 11, 2026
July 1, 2026
4 months
July 31, 2026
August 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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%
Baseline and 6 months
Secondary Outcomes (4)
Change in Fasting Blood Glucose (FBG)
Baseline, 3 months, and 6 months
Change in Lipid Profile Parameters
Baseline and 6 months
Change in Neuropathic Pain Intensity
Baseline and 6 months (or Baseline, 3 months, and 6 months according to your protocol)
Change in Diabetes Self-Efficacy Score
Baseline and 6 months
Study Arms (3)
Matching Placebo Group
ACTIVE COMPARATORParticipants receive routine diabetes medical care and matching placebo capsules administered twice daily for 6 months.
Ceylon Cinnamon Group
EXPERIMENTALParticipants receive routine diabetes medical care and pure Ceylon cinnamon (Cinnamomum verum) extract capsules (500 mg orally twice daily, total daily dose: 1,000 mg) for 6 months.
Combined Intervention Group
EXPERIMENTALParticipants receive routine diabetes medical care, 1,000 mg/day Ceylon cinnamon supplementation for 6 months, and a structured Self-Efficacy-Based Educational Program grounded in Bandura's social cognitive theory.
Interventions
Pure Ceylon cinnamon extract capsules (500 mg per capsule, taken twice daily, total dose 1,000 mg/day for 6 months).
Placebo capsules identical in appearance, color, and packaging to the cinnamon supplement, taken twice daily for 6 months
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Concurrent participation in another clinical trial or severe psychiatric/cognitive disorders that hinder study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- A double-blind, placebo-controlled design is implemented for the supplementation component (participants, care providers, investigators, and outcomes assessors are blinded to the cinnamon vs. placebo assignment). The educational intervention component is open-label for participants and educators, but outcomes assessors and data analysts remain blinded to group allocations.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ASST.PROF.DR
Study Record Dates
First Submitted
July 31, 2026
First Posted
August 11, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
August 11, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share