Impact of Resveratrol and Pharmaceutical Care on Diabetes Mellitus and Its Neuropathic Complication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- visual analog scale (VAS)
研究概览
简要总结
Management of symptoms associated with diabetic neuropathy is a difficult issue for clinicians since it usually does not respond to standard analgesics. Resveratrol is a naturally occurring plant-derived, polyphenolic compound, it exerts pleiotropic activity. The investigators believed that the implementation of multidisciplinary approaches including pharmacotherapy and provision of healthcare professional services such as pharmacist intervention are needed for alleviation of diabetic associated neuropathy.Therefore, the hypothesis of the present protocol is that the administration of resveratrol and/or provision of pharmaceutical care in patients with diabetic neuropathy might be of value in improving quality of life and managing diabetic neuropathic pain.The study is designed as a four-arm randomized, placebo-controlled clinical trial. Group one will be given only conventional hypoglycemic drugs. Group two patients will receive conventional hypoglycemic drugs accompanied by pharmacist interventions. Group three; patients will receive resveratrol 500 mg orally once daily after meals for three months, in addition to their regular hypoglycemic drugs. Group four; patients will receive resveratrol 500 mg orally once daily after meals along with their regular hypoglycemic drugs for a period of three months, accompanied by pharmacist interventions. Neuropathic pain will be measured by various neuropathic pain assessment tools. Nerve conduction studies will be performed to assess the effect of interventional therapy. The expected outcome will be the improvement of diabetic neuropathy associated symptoms along with glycemic status.
详细描述
- Diabetic neuropathy is the most common microvascular complication of diabetes, resulting from prolonged periods of hyperglycemia, damaging fragile nerve fibers and the walls of their blood vessels.
- Despite clinical developments in the treatment of diabetes complications, especially diabetic neuropathy, it still remains a clinical challenge with no effective solution.
- Conventional therapies such as anti-epileptics, opioid analgesics, and antidepressants for the treatment of neuropathic pain are quite challenging due to their serious adverse effects.
- There is a need to investigate novel effective and safe options.
- Recently, polyphenols have also been introduced as potential neuroprotective agents in diabetes.
- Alleviation of the symptoms associated with diabetic neuropathy and exerting preventive measures to halt the emergence of neuropathy complications are crucial priorities, and this requires multidisciplinary approaches including pharmacotherapy and provision of healthcare professional services such as pharmacist intervention.
- Aim of the study: to evaluate the effects of resveratrol and pharmaceutical care on the severity of diabetic neuropathy and improvement in the quality of life of diabetic patients.
- Study design: four-arm randomized, double-blind, placebo-controlled clinical trial.
- Interventions:Therapeutic intervention and Pharmacist intervention.
- Number of participants = 120
- Number of groups = 4 groups each of 30 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A prospective triple blind randomized clinical trial
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pain due to bilateral peripheral neuropathy caused by type 2 diabetes mellitus.
- •HbA1c of greater than 7%
- •The daily pain must be present for at least 6 months, and the diagnosis will be confirmed by a score >4 on the Michigan Neuropathy Screening Instrument (MNSI), Douleur Neuropathique 4 (DN4). The severity of pain when evaluated for the past 24 was ≥4 on the 10 cm Visual Analogue Scale (VAS) at baseline without the use of analgesic for 48 hours.
排除标准
- •Older subjects with high risks of cardiovascular diseases,
- •Pregnant or breastfeeding,
- •Having a prior renal transplant or current renal dialysis,
- •Patients have a diagnosis of major depressive disorder, generalized anxiety disorder, heavy alcohol drinkers,
- •Significant hepatic or renal disease,
- •Patients on antioxidant therapy, or pentoxyphylline within the last month.
研究组 & 干预措施
Resveratrol
Interventional group, participants in this group are receiving Resveratrol 500mg capsule once daily for 3 months.
干预措施: Resveratrol (Drug)
Placebo
Non-interventional group, participants are receiving only Placebo once daily for 3 months.
Placebo formulated as capsule match the color and size of the active comparator,
干预措施: Placebo (Drug)
Resveratrol plus Pharmaceutical care
Interventional group, participants in this group are receiving Resveratrol 500mg capsule once daily for 3 months with pharmaceutical care.
干预措施: Resveratrol plus Pharmaceutical care (Other)
Placebo with pharmaceutical care
Interventional group, participants are receiving placebo along with pharmaceutical care for 3 months.
干预措施: Placebo+Pharmaceutical care (Other)
结局指标
主要结局
visual analog scale (VAS)
时间窗: up to 3 months
to assess neuropathic pain, VAS scale ranges between 0-10 , 0 indicates no pain while 10 indicates severe pain.
Serum neopterin levels
时间窗: up to 3 months
biochemical marker for peripheral neuropathy
Douleur Neuropathique 4 questionnaire (DN4)
时间窗: up to 3 months
to assess the severity of diabetic peripheral neuropathy.
The Michigan Neuropathy Screening Instrument (MNSI)
时间窗: up to 3 months
to assess the severity of diabetic peripheral neuropathy
Electroneurography
时间窗: up to 3 months
Motor nerve conduction velocity (m/s), sensory nerve conduction velocity(m/s) will be measured using surface electrodes.
Assessment of Quality of Life
时间窗: up to 3 months
using the RAND-36 health survey questionnaire
次要结局
- The mean change in fasting blood glucose(up to 3 months)
- Measurement of serum level of LDL, cholesterol, HDL, Triglyceride(up to 3 months)
- Mean change of glycated hemoglobin (HbA1c)-mmol/l(up to 3 months)
研究者
Bushra Hassan Marouf
Assistant Professor at Pharmacology and Toxicology Department
University of Sulaimani