An interventional study of Ceylon Cinnamon (Cinnamomum verum) Supplement and Matching Placebo in Type 2 Diabetes Mellitus and Painful Diabetic Peripheral Neuropathy (PDPN), sponsored by Jerash Private University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Jerash Private University · Not applicable, Interventional, and Prevention
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 900 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Jerash Private University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive routine diabetes medical care and matching placebo capsules administered twice daily for 6 months.
Other: Matching Placebo
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.
Dietary Supplement: Ceylon Cinnamon (Cinnamomum verum) Supplement · Other: Matching Placebo
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.
Dietary Supplement: Ceylon Cinnamon (Cinnamomum verum) Supplement · Behavioral: Self-Efficacy-Based Educational Program
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
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%
Time frame: Baseline and 6 months
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).
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: Baseline and 6 months
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Plan to share: No
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Jerash Private University