NCT07743073

Brief Summary

Background: Painful diabetic peripheral neuropathy (PDPN) is a severe, disabling complication of type 2 diabetes mellitus (T2DM), closely associated with insulin resistance, chronic neuroinflammation, and oxidative stress. Plant-based dietary supplements, particularly Ceylon cinnamon (Cinnamomum verum), contain bioactive compounds with potential anti-diabetic, antioxidant, and neuroprotective properties. Aim: To evaluate the effects of Ceylon Cinnamon (Cinnamomum verum) supplementation on blood glucose, lipid profile levels, body mass index (BMI), and pain intensity among adult individuals with painful diabetic peripheral neuropathy (PDPN). Methods: A prospective, double-blind, randomized controlled trial (Double-Blind RCT) was conducted (Feb-July 2026) across endocrinology outpatient clinics in Jordan. Participants were randomly allocated in a 1:1 ratio to either the Intervention Group (n = 62; 500 mg Ceylon cinnamon twice daily for 6 months alongside standard care) or the Placebo Control Group (n = 62; 500 mg placebo capsules twice daily for 6 months alongside standard care). Clinical, biochemical, and pain assessments (using the Numeric Rating Scale \[NRS\]) were evaluated at baseline, 3 months, and 6 months post-intervention.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
Last Updated

August 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

July 29, 2026

Last Update Submit

July 29, 2026

Conditions

Painful Diabetic Peripheral Neuropathy

Keywords

Painful diabetic peripheral neuropathyCeylon cinnamon (Cinnamomum verum)Insulin resistanceNeuropathic pain

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity

    Measured using a validated scale (such as the Visual Analog Scale - VAS or Numeric Rating Scale - NRS) to assess changes in neuropathic pain severity among participants.

    Baseline and at the end of the intervention period ( 6 months).

Secondary Outcomes (1)

  • Change in Blood Glucose Levels

    Baseline and at the end of the intervention period ( 6 months).

Other Outcomes (1)

  • Change in Lipid Profile Levels

    Baseline and at the end of the intervention period ( 6 months).

Study Arms (2)

Ceylon Cinnamon Group

EXPERIMENTAL

Participants receive Ceylon Cinnamon supplementation daily for a specified duration.

Dietary Supplement: Ceylon Cinnamon Supplement

Control Group

PLACEBO COMPARATOR

Participants receive a matching placebo daily for the same duration.

Dietary Supplement: Ceylon Cinnamon Supplement

Interventions

Ceylon Cinnamon SupplementDIETARY_SUPPLEMENT

500 mg Ceylon cinnamon twice daily for 6 months

Also known as: Placebo
Ceylon Cinnamon GroupControl Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18years diagnosed with PDPN
  • With documented T2DM

You may not qualify if:

  • If they had coexisting chronic conditions, including chronic kidney disease (CKD), hypertension, cardiovascular disease (CVD), or cognitive/sensory impairments (e.g., reading or hearing difficulties).
  • individuals receiving medications that could confound blood glucose control or pain perception (such as systemic glucocorticoids, weight-loss agents, or iron and vitamin B12 supplements)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health Primary Healthcare Centers

Amman, 009627, Jordan

RECRUITING

MeSH Terms

Conditions

Insulin ResistanceNeuralgia

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Dr. Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr

CONTACT

+962779084560JAWAD_0799@YAHOO.COM

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to two parallel groups: the intervention group receiving Ceylon Cinnamon supplementation and the control group receiving a matching placebo, with neither group crossing over to the other treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 3, 2026

Study Start

February 1, 2026

Primary Completion

May 30, 2026

Study Completion

July 30, 2026

Last Updated

August 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)