Effect of melatonin supplement versus placebo on the severity of pain, sleep disorder, and quality of life in patients with painful diabetic neuropathy

Effect of melatonin supplement versus placebo on the severity of pain, sleep disorder, and quality of life in patients with painful diabetic neuropathy: a double-blind randomized clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N299

Enrollment

116

Registered

2019-09-23

Start date

2019-09-23

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Painful diabetic neuropathy. Type 2 diabetes mellitus with diabetic neuropathy, unspecified

Interventions

Intervention 1: Intervention group: Tablet pregabalin 75 mg daily plus tablet melatonin 6 mg twice daily for 8 weeks. Intervention 2: Control group: Tablet pregabalin 75 mg daily plus tablet placebo t

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age of 18 to 70 years, Type 2 diabetes for at least one year, Painful neuropathy

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding, Foot ulcer of infection, Hemoglobin A1c =9, Cerebrovascular Diseases and discopathy, Using anti-inflammatory and analgesic drugs, Drinking alcohol or using opioid substances

Design outcomes

Primary

Measure	Time frame
Mean score of pain. Timepoint: Before the intervention and at the second, forth, and eighth weeks after the intervention. Method of measurement: Using Visual Analog Scale (VAS).;Mean score of sleep disorder. Timepoint: Before the intervention and at the second, forth, and eighth weeks after the intervention. Method of measurement: Using standard questionnaire.;Mean score of Clinical Global Impression of Change (CGIC). Timepoint: Before the intervention and at the eighth week after the intervention. Method of measurement: Using the standard questionnaire.	—

Measure

Time frame

Mean score of pain. Timepoint: Before the intervention and at the second, forth, and eighth weeks after the intervention. Method of measurement: Using Visual Analog Scale (VAS).;Mean score of sleep disorder. Timepoint: Before the intervention and at the second, forth, and eighth weeks after the intervention. Method of measurement: Using standard questionnaire.;Mean score of Clinical Global Impression of Change (CGIC). Timepoint: Before the intervention and at the eighth week after the intervention. Method of measurement: Using the standard questionnaire.

—

Secondary

Measure	Time frame
Mean score of quality of life. Timepoint: Before the intervention and at the eighth week after the intervention. Method of measurement: Using the SF-36 questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Shokri

Hamedan University of Medical Sciences

maryamshokri993@gmail.com+98 81 3838 0572

Outcome results

None listed

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