Effect of Resveratrol and Pharmacist Intervention on Diabetes Mellitus and Its Neuropathic Complication
Condition: Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies; Diabetes Mellitus
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      -  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
    

Intervention name(s): Resveratrol; Placebo; Resveratrol plus Pharmaceutical care; Placebo+Pharmaceutical care
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): This group received resveratrol with the conventional therapy; This group received placebo with the conventional therapy; This group received Resveratrol with Pharmaceutical care in addition to the conventional therapy; This group received placebo with Pharmaceutical care in addition to the conventional therapy
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible patients assigned to either conventional hypoglycemic drugs without pharmaceutical care, or conventional hypoglycemic drugs accompanied with pharmacist interventions or patients will receive resveratrol 500 mg capsules orally once daily with their regular hypoglycemic drugs or resveratrol 500 mg capsule orally along with their regular hypoglycemic drugs for a period of three months, accompanied with pharmacist interventions.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic neuropathy; Neuropathic pain; pharmaceutical care; Resveratrol