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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220429054695N1
Enrollment
60
Registered
2022-11-21
Start date
2022-11-21
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic neuropathy. Type 2 diabetes mellitus with neurological complications

Interventions

Intervention 1: The study intervention group includes 20 patients of both genders, aged 25 to 70 years, with diabetic neuropathy pain, who receive evening primrose soft capsules at a dose of 1000 mg e

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAyoub Gholami

Islamic Azad University

gholamiauob69g@mail.com+98 21 2264 0051

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026