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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol | Active Comparator | Interventional group, participants in this group are receiving Resveratrol 500mg capsule once daily for 3 months. |
|
| Placebo | Placebo Comparator | 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, |
|
| Resveratrol plus Pharmaceutical care | Other | Interventional group, participants in this group are receiving Resveratrol 500mg capsule once daily for 3 months with pharmaceutical care. |
|
| Placebo with pharmaceutical care | Other | Interventional group, participants are receiving placebo along with pharmaceutical care for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Drug | This group received resveratrol with the conventional therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| visual analog scale (VAS) | to assess neuropathic pain, VAS scale ranges between 0-10 , 0 indicates no pain while 10 indicates severe pain. | up to 3 months |
| Douleur Neuropathique 4 questionnaire (DN4) | to assess the severity of diabetic peripheral neuropathy. | up to 3 months |
| The Michigan Neuropathy Screening Instrument (MNSI) | to assess the severity of diabetic peripheral neuropathy | up to 3 months |
| Electroneurography | Motor nerve conduction velocity (m/s), sensory nerve conduction velocity(m/s) will be measured using surface electrodes. | up to 3 months |
| Assessment of Quality of Life | using the RAND-36 health survey questionnaire | up to 3 months |
| Serum neopterin levels | biochemical marker for peripheral neuropathy | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in fasting blood glucose | to assess glycemic status | up to 3 months |
| Mean change of glycated hemoglobin (HbA1c)-mmol/l | to assess glycemic status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bushra Marouf, PhD | Department of Pharmacology and Toxicology-College of Pharmacy-University of Sulaimani | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Pharmacy-University of Sulaimani | Sulaymānīyah | 00964 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30565054 | Background | Azmi S, ElHadd KT, Nelson A, Chapman A, Bowling FL, Perumbalath A, Lim J, Marshall A, Malik RA, Alam U. Pregabalin in the Management of Painful Diabetic Neuropathy: A Narrative Review. Diabetes Ther. 2019 Feb;10(1):35-56. doi: 10.1007/s13300-018-0550-x. Epub 2018 Dec 18. | |
| 20961643 | Background | Collins C, Limone BL, Scholle JM, Coleman CI. Effect of pharmacist intervention on glycemic control in diabetes. Diabetes Res Clin Pract. 2011 May;92(2):145-52. doi: 10.1016/j.diabres.2010.09.023. Epub 2010 Oct 20. |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D010593 | Pharmaceutical Services |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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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.
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A prospective triple blind randomized clinical trial
| Placebo |
| Drug |
This group received placebo with the conventional therapy |
|
| Resveratrol plus Pharmaceutical care | Other | This group received Resveratrol with Pharmaceutical care in addition to the conventional therapy |
|
| Placebo+Pharmaceutical care | Other | This group received placebo with Pharmaceutical care in addition to the conventional therapy |
|
| up to 3 months |
| Measurement of serum level of LDL, cholesterol, HDL, Triglyceride | to assess the effect of the interventions on metabolic changes | up to 3 months |
| 29627577 | Background | Elbarbary NS, Ismail EAR, El-Hilaly RA, Ahmed FS. Role of neopterin as a biochemical marker for peripheral neuropathy in pediatric patients with type 1 diabetes: Relation to nerve conduction studies. Int Immunopharmacol. 2018 Jun;59:68-75. doi: 10.1016/j.intimp.2018.03.026. Epub 2018 Apr 6. |
| 31352568 | Background | Naseri R, Farzaei F, Fakhri S, El-Senduny FF, Altouhamy M, Bahramsoltani R, Ebrahimi F, Rahimi R, Farzaei MH. Polyphenols for diabetes associated neuropathy: Pharmacological targets and clinical perspective. Daru. 2019 Dec;27(2):781-798. doi: 10.1007/s40199-019-00289-w. Epub 2019 Jul 27. |
| 31346658 | Background | Eid S, Sas KM, Abcouwer SF, Feldman EL, Gardner TW, Pennathur S, Fort PE. New insights into the mechanisms of diabetic complications: role of lipids and lipid metabolism. Diabetologia. 2019 Sep;62(9):1539-1549. doi: 10.1007/s00125-019-4959-1. Epub 2019 Jul 25. |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |