Effects of Evening Primrose Oil for Treating Painful Diabetic Neuropathy: A randomized, double-blind, clinical trial

Phase 3

Recruiting

• Conditions: Diabetic neuropathy.; Type 2 diabetes mellitus with neurological complications; E11.4

• Registration Number: IRCT20220429054695N1
• Lead Sponsor: Islamic Azad University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Having written informed consent
Age 20-75 years old
At least one year of type 2 diabetes
Hemoglobin A1C level is smaller equal to 11%
Patients should have a VAS score of 4 or more
Diagnosing chronic diabetic neuropathy based on Michigan score 2 or more and ruling out other causes of neuropathy by the doctor

Exclusion Criteria

Confounding neurologic disease or neuropathy from progressive or degenerative disorders that may interfere with assessment of DPN severity.
Fractures and traumatic injuries leading to sensory and motor lesions in the lower limbs
uncontrolled blood pressure (systolic or diastolic blood pressure level =160 or =100 mm Hg or =95 or =60 mm Hg, respectively)
leg amputation;
The presence of wounds and infections in the foot
heart, lung, gastrointestinal, blood, or other clinically significant endocrine disease (eg, abnormal thyroid function test even with medication).
organ transplantation;
AST or ALT levels more than 3 times the normal level.
Serum creatinine level > 2 mg/dl.
abuse of drugs or alcohol in the last year;
use of an investigational drug in the last 6 months;
severe or anaphylactic drug reactions;.
History of allergy to medicinal plants
pregnant or lactating women;
Corticosteroid treatments in the last 2 months
If the patients have used TCA drugs, SNRIs, gabapentinoid drugs, opioids and local treatments of capsaicin and anesthetics in the last two weeks or currently (in some patients, if possible, at the discretion of the attending physician, These drugs can be discontinued for 2 weeks and then the patient will enter the study. During these 2 weeks, acetaminophen will be used to relieve the pain of these patients).
Patients treated with anticonvulsant drugs and history of seizures or schizophrenia
Patients with hemophilia or other bleeding disorders and people receiving anticoagulants and warfarin

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Michigan and McGill Neuropathy Questionnaire Score. Timepoint: After 4 weeks compared to the base score. Method of measurement: Michigan and McGill Neuropathy Questionnaire.