he effect of pregabalin and melatonin on diabetic neuropathy

Comparison of the effect of pregabalin and melatonin on the Severity of Pain caused by painful diabetic polyneuropathy, a double-blind clinical trial study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191030045277N3

Enrollment

Registered

2024-02-09

Start date

2024-04-03

Completion date

Unknown

Last updated

2024-03-06

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

Conditions

Diabetic polyneuropathy. Type 2 diabetes mellitus with diabetic polyneuropathy

Interventions

Intervention 1: Intervention group: Patients in this group will be treated with pregabalin 75 mg (Razak Pharmaceutical Company). Its duration will be 35 days. Intervention 2: Intervention group: Patie

Eligibility

Sex/Gender

All

Age

30 Years to 65 Years

Inclusion criteria

Inclusion criteria: All patients with diabetic neuropathy

Exclusion criteria

Exclusion criteria: Pregnancy and lactation Recent Myocardial Infarction History of seizures Gastroparesis and diabetic cystopathy Sensitivity to medications (pregabalin and melatonin) Mood disorder hypothyroidism and hyperthyroidism Liver and Renal failure people with arthritis Hereditary neuropathies People with a history of trauma and degenerative bone lesions

Design outcomes

Primary

Measure	Time frame
Severity of neuropathy. Timepoint: At the beginning of the study (first day) and at the end of the second week and at the end of the study (end of the fifth week). Method of measurement: Based on the VAS (Visual Analogue Scale).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadali Bayani

Babol University of Medical Sciences

bayanima49@yahoo.com+98 11 3223 8309

Outcome results

None listed

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