Type 2 Diabetes MellitusCeylon-EDU-RCTNCT07757399
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
A study testing Ceylon Cinnamon (Cinnamomum verum) Supplement and Self-Efficacy-Based Educational Program in people with Type 2 Diabetes Mellitus and Painful Diabetic Peripheral Neuropathy (PDPN), run by Jerash Private University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Painful Diabetic Peripheral Neuropathy (PDPN)
- What is being tested?
- Ceylon Cinnamon (Cinnamomum verum) Supplement and Self-Efficacy-Based Educational Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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: A Randomized Controlled 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.
Read the detailed description
Type 2 diabetes mellitus (T2DM) is a major global health challenge often complicated by diabetic peripheral neuropathy (DPN), which frequently manifests as painful diabetic peripheral neuropathy (PDPN) and severely compromises patients' quality of life. Conventional pharmacological treatments for PDPN often produce limited efficacy and adverse side effects, necessitating safe and effective complementary interventions.
This study is a prospective, three-group, parallel-arm, randomized controlled trial (RCT) designed to investigate the synergistic therapeutic impact of botanical supplementation and behavioral education. A total of 900 eligible adult participants diagnosed with T2DM and PDPN attending clinical healthcare centers will be enrolled and randomly allocated in a 1:1:1 ratio into one of three trial arms:
Control Group (Standard Care, n = 300): Participants receive routine diabetic medical care, standard counseling, and matching placebo capsules administered twice daily for 6 months, without structured educational interventions.
Cinnamon Supplementation Group (n = 300): Participants receive standard routine care alongside pure Ceylon cinnamon (Cinnamomum verum) extract capsules (500 mg orally twice daily with meals, total daily dose: 1,000 mg) for 6 months, combined with a double-blind placebo control for the educational component.
Combined Intervention Group (n = 300): Participants receive the identical daily regimen of 1,000 mg Ceylon cinnamon supplementation for 6 months, integrated with a structured, theory-driven Self-Efficacy-Based Educational Program grounded in Bandura's social cognitive theory. The educational program focuses on self-monitoring of blood glucose (SMBG), medication and supplement adherence, dietary modifications, foot care, and psychological coping strategies for chronic pain.
Primary and Secondary Endpoints:
Evaluations will be conducted at baseline and 6 months post-intervention. Primary outcomes include changes in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), insulin resistance (HOMA-IR), and neuropathic pain severity assessed via the Numeric Rating Scale (NRS). Secondary outcomes include lipid profile biomarkers (Total Cholesterol, Triglycerides, LDL-C, and HDL-C), patient adherence, and safety/adverse event tracking. Statistical analyses will utilize repeated measures ANOVA and mixed-model frameworks to evaluate longitudinal and between-group differences.
- Being tested
- Ceylon Cinnamon (Cinnamomum verum) Supplement, Matching Placebo, Self-Efficacy-Based Educational Program
- Keywords
- Ceylon Cinnamon, Self-Efficacy Educational Program, Glycemic Control, Neuropathic Pain, Randomized Controlled Trial
- Medical subject headings
- Diabetes Mellitus, Type 2, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceylon Cinnamon (Cinnamomum verum) SupplementDietary supplement
Pure Ceylon cinnamon extract capsules (500 mg per capsule, taken twice daily, total dose 1,000 mg/day for 6 months).
Matching PlaceboOther
Placebo capsules identical in appearance, color, and packaging to the cinnamon supplement, taken twice daily for 6 months
Self-Efficacy-Based Educational ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Matching Placebo Group | Active comparator | Participants receive routine diabetes medical care and matching placebo capsules administered twice daily for 6 months. Receives: Other: Matching Placebo |
| Ceylon Cinnamon Group | Experimental | Participants 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. Receives: Dietary Supplement: Ceylon Cinnamon (Cinnamomum verum) Supplement; Other: Matching Placebo |
| Combined Intervention Group | Experimental | Participants 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. Receives: Dietary Supplement: Ceylon Cinnamon (Cinnamomum verum) Supplement; Behavioral: Self-Efficacy-Based Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: Baseline and 6 months
Secondary outcomes (4)
Change in Fasting Blood Glucose (FBG)
Description: Evaluated from venous blood samples collected following an 8-hour overnight fast, measured in milligrams per deciliter (mg/dL). Lower values indicate a better outcome (improved fasting glycemic status).
Measured: Baseline, 3 months, and 6 months
Change in Lipid Profile Parameters
Evaluated from venous blood samples collected following an 8-hour overnight fast, measured in milligrams per deciliter (mg/dL). Directionality of improvement varies by component:
Total Cholesterol: Lower values indicate a better outcome.
Triglycerides: Lower values indicate a better outcome.
Low-Density Lipoprotein Cholesterol (LDL-C): Lower values indicate a better outcome.
High-Density Lipoprotein Cholesterol (HDL-C): Higher values indicate a better outcome.
Measured: Baseline and 6 months
Change in Neuropathic Pain Intensity
Evaluated using the Numerical Rating Scale (NRS). Participants rate their average neuropathic pain intensity over the preceding 7 days. Scores range from a minimum value of 0 (no pain) to a maximum value of 10 (worst possible pain). Higher scores indicate a worse outcome (greater pain intensity). Pain severity is categorized as mild (1-3), moderate (4-7), or severe (8-10).
Measured: Baseline and 6 months (or Baseline, 3 months, and 6 months according to your protocol)
Change in Diabetes Self-Efficacy Score
Evaluated using the Diabetes Self-Efficacy Scale (DSES). Item scores range from a minimum value of 1 (not at all confident) to a maximum value of 10 (totally confident), reported as an overall mean score (range 1-10). Higher scores indicate
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, three-group, parallel-arm, randomized controlled trial where eligible participants are allocated in a 1:1:1 ratio into three study arms: a standard care control group, a Ceylon cinnamon supplementation group, and a combined intervention group (Ceylon cinnamon supplementation plus a self-efficacy educational program).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jerash Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAWAD AHMAD ABU-SHENNAR, Jerash Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757399
- Sponsor's protocol ID
- Educat vs. Ceyl-2026
- Acronym
- Ceylon-EDU-RCT
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07757399
- Acronym / sponsor ID
- Ceylon-EDU-RCT / Educat vs. Ceyl-2026
- Keywords
- Ceylon Cinnamon, Self-Efficacy Educational Program, Glycemic Control, Neuropathic Pain, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Jerash Private UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 2 diabetes mellitus (T2DM) is a major global health challenge often complicated by diabetic peripheral neuropathy (DPN), which frequently manifests as painful diabetic peripheral neuropathy (PDPN) and severely compromises patients' quality of life. Conventional pharmacological treatments for PDPN often produce limited efficacy and adverse side effects, necessitating safe and effective complementary interventions.
This study is a prospective, three-group, parallel-arm, randomized controlled trial (RCT) designed to investigate the synergistic therapeutic impact of botanical supplementation and behavioral education. A total of 900 eligible adult participants diagnosed with T2DM and PDPN attending clinical healthcare centers will be enrolled and randomly allocated in a 1:1:1 ratio into one of three trial arms:
Control Group (Standard Care, n = 300): Participants receive routine diabetic medical care, standard counseling, and matching placebo capsules administered twice daily for 6 months, without structured educational interventions.
Cinnamon Supplementation Group (n = 300): Participants receive standard routine care alongside pure Ceylon cinnamon (Cinnamomum verum) extract capsules (500 mg orally twice daily with meals, total daily dose: 1,000 mg) for 6 months, combined with a double-blind placebo control for the educational component.
Combined Intervention Group (n = 300): Participants receive the identical daily regimen of 1,000 mg Ceylon cinnamon supplementation for 6 months, integrated with a structured, theory-driven Self-Efficacy-Based Educational Program grounded in Bandura's social cognitive theory. The educational program focuses on self-monitoring of blood glucose (SMBG), medication and supplement adherence, dietary modifications, foot care, and psychological coping strategies for chronic pain.
Primary and Secondary Endpoints:
Evaluations will be conducted at baseline and 6 months post-intervention. Primary outcomes include changes in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), insulin resistance (HOMA-IR), and neuropathic pain severity assessed via the Numeric Rating Scale (NRS). Secondary outcomes include lipid profile biomarkers (Total Cholesterol, Triglycerides, LDL-C, and HDL-C), patient adherence, and safety/adverse event tracking. Statistical analyses will utilize repeated measures ANOVA and mixed-model frameworks to evaluate longitudinal and between-group differences.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- A prospective, three-group, parallel-arm, randomized controlled trial where eligible participants are allocated in a 1:1:1 ratio into three study arms: a standard care control group, a Ceylon cinnamon supplementation group, and a combined intervention group (Ceylon cinnamon supplementation plus a self-efficacy educational program).
| Arm | Type | Receives |
|---|---|---|
| Matching Placebo Group | Active comparator | Other: Matching PlaceboParticipants receive routine diabetes medical care and matching placebo capsules administered twice daily for 6 months. |
| Ceylon Cinnamon Group | Experimental | Dietary Supplement: Ceylon Cinnamon (Cinnamomum verum) Supplement, Other: Matching PlaceboParticipants 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 | Experimental | Dietary Supplement: Ceylon Cinnamon (Cinnamomum verum) Supplement, Behavioral: Self-Efficacy-Based Educational ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceylon Cinnamon (Cinnamomum verum) SupplementPure Ceylon cinnamon extract capsules (500 mg per capsule, taken twice daily, total dose 1,000 mg/day for 6 months). | Dietary supplement | Ceylon Cinnamon Group, Combined Intervention Group |
| Matching PlaceboPlacebo capsules identical in appearance, color, and packaging to the cinnamon supplement, taken twice daily for 6 months | Other | Ceylon Cinnamon Group, Matching Placebo Group |
| Self-Efficacy-Based Educational ProgramA 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 | Behavioural | Combined Intervention Group |
Primary outcome
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline and 6 months
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%
4 secondary outcomes
Change in Fasting Blood Glucose (FBG)
Time frame: Baseline, 3 months, and 6 months
Change in Lipid Profile Parameters
Time frame: Baseline and 6 months
Change in Neuropathic Pain Intensity
Time frame: Baseline and 6 months (or Baseline, 3 months, and 6 months according to your protocol)
Change in Diabetes Self-Efficacy Score
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ceylon Cinnamon (Cinnamomum verum) Supplement and Self-Efficacy-Based Educational Program in people with Type 2 Diabetes Mellitus and Painful Diabetic Peripheral Neuropathy (PDPN), run by Jerash Private University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr (+962779084560, JAWAD_0799@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (HbA1c) (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.