Effect of Resveratrol and Pharmacist Intervention on Diabetes Mellitus and Its Neuropathic Complication

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.

Conditions

• Diabetic Neuropathies

Interventions

DRUG

Resveratrol

This group received resveratrol with the conventional therapy

DRUG

Placebo

This group received placebo with the conventional therapy

OTHER

Resveratrol plus Pharmaceutical care

This group received Resveratrol with Pharmaceutical care in addition to the conventional therapy

OTHER

Placebo+Pharmaceutical care

This group received placebo with Pharmaceutical care in addition to the conventional therapy

Sponsors & Collaborators

• University of Sulaimani

  lead OTHER

Principal Investigators

• Bushra Marouf, PhD · Department of Pharmacology and Toxicology-College of Pharmacy-University of Sulaimani

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-05

Primary Completion

2022-12-01

Completion

2022-12-15

Countries

• Iraq

Study Locations