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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 900
- 主要终点
- Change in Glycated Hemoglobin (HbA1c)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ceylon Cinnamon Group
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.
干预措施: Matching Placebo (Other)
Matching Placebo Group
Participants receive routine diabetes medical care and matching placebo capsules administered twice daily for 6 months.
干预措施: Matching Placebo (Other)
Ceylon Cinnamon Group
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.
干预措施: Ceylon Cinnamon (Cinnamomum verum) Supplement (Dietary Supplement)
Combined Intervention Group
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.
干预措施: Ceylon Cinnamon (Cinnamomum verum) Supplement (Dietary Supplement)
Combined Intervention Group
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.
干预措施: Self-Efficacy-Based Educational Program (Behavioral)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c)
时间窗: 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%
次要结局
- 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)
研究者
JAWAD AHMAD ABU-SHENNAR
ASST.PROF.DR
Jerash Private University