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Study of effect of olive leaves on diabetic neuropathy

Comparing the effectiveness of olive leaf extract and Pregabalin on symptomatic treatment of diabetic neuropathy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100513003922N4
Enrollment
66
Registered
2019-01-08
Start date
2018-12-22
Completion date
Unknown
Last updated
2019-08-26

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

Conditions

Diabetic neuropathy. Diabetic autonomic neuropathy

Interventions

Intervention 1: Intervention group: Olive leaf extract (capsule) is given orally three times a day for three consecutive months. Intervention 2: Control group: Pregabalin is prescribed orally twice a

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Type I and II diabetic patients who have diabetes for at least one year and have diabetic neuropathy pain History of neuropathic pain for at least three months a pain score (VSA) equal to or greater than 4 at least 18 years of age or older HbA1c is equal to or less than 11

Exclusion criteria

Exclusion criteria: Pregnant and lactating women ischemic pain or other pain such as pains associated with amputation or arthritis Electroconvulsive Therapy in the past 30 days using warfarin, antiarrhythmic drugs, sedatives, hypnotices, anticonvulsants, NSAIDs and capsaicin in the past 7 days using antipsychotics, antidepressants, opioids and muscle relaxants during the past 14 days using anti-neuropathic drug and Unwillingness to stop taking it Dependence on alcohol or other drugs important metabolic diseases, cardiovascular diseases, thyroid disease, major blood diseases, reduced kidney function or liver function, bipolar disease, psychosis history of suicide drug sensitivity

Design outcomes

Secondary

MeasureTime frame
Quality of life score. Timepoint: At the beginning of the study and at the end of the third month of the study. Method of measurement: Quality of life questionnaire SF-36.;Diarrhea. Timepoint: during the study. Method of measurement: questionnaire of patient-reported side effects.;Stomach ache. Timepoint: during the study. Method of measurement: questionnaire of patient-reported side effects.

Primary

MeasureTime frame
Pain score on visual analog scale. Timepoint: At the end of each month for three consecutive months. Method of measurement: visual analog scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Masoud Modarresi

Kermanshah University of Medical Sciences

mmodarresi@kums.ac.ir+98 83 3427 6482

Outcome results

None listed

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