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Effects of topical gel Silymarin versus placebo as an adjuvant therapy on pain management in patients with painful diabetic neuropathy

Effects of topical gel Silymarin versus placebo as an adjuvant therapy on pain management in patients with painful diabetic neuropathy: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120215009014N501
Enrollment
50
Registered
2024-02-29
Start date
2024-03-25
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

Painful diabetic neuropathy. Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified

Interventions

Intervention 1: Intervention group: Pregabalin 75 mg tablet at night plus 3% silymarin topical gel twice a day for 2 months. Intervention 2: Control group: Pregabalin 75 mg tablet at night plus placeb

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age of 18 to 65 years Diabetes mellitus type 1 or 2 Painful diabetic neuropathy

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Drug abuse Nondiabetic neuropathy Diabetic ulcer Liver or kidney disease

Design outcomes

Primary

MeasureTime frame
Pain score. Timepoint: Before intervention and one and two months later. Method of measurement: Using visual analog scale (VAS).;Quality of life score. Timepoint: Before the intervention and one and two months later. Method of measurement: Using the World Health Organization Quality of Life Questionnaire.

Secondary

MeasureTime frame
Local complication (redness, itching). Timepoint: One and two months later the intervention. Method of measurement: By taking history and clinical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Khodarahmi Ghahnavieh

Hamedan University of Medical Sciences

mkh.1999.94@gmail.com+98 81 3838 0572

Outcome results

None listed

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