The effect of nortriptyline and melatonin on diabetic neuropathy

Comparison of the effect of nortriptyline and melatonin on the severity of diabetic polyneuropathy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191030045277N2

Enrollment

Registered

2020-10-15

Start date

2019-12-22

Completion date

Unknown

Last updated

2020-11-09

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

Conditions

Condition 1: Diabetic polyneuropathy. Condition 2: Diabetic polyneuropathy. Type 1 diabetes mellitus with diabetic polyneuropathy Type 2 diabetes mellitus with diabetic polyneuropathy

Interventions

Intervention 1: Intervention group : Patients in this group will be treated with nortriptyline 25 mg (Sobhan Pharmaceutical Company). Its duration will be 35 days. Intervention 2: Intervention group:

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 Sensitivity to medications (nortriptyline and melatonin) History of seizures Mood disorder Gastroparesis and diabetic cystopathy, Liver and Renal failure hypothyroidism and hyperthyroidism 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