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The efficacy and safety of Silymarin in chemotherapy-induced peripheral neuropathy (CIPN)

The efficacy and safety of Silymarin in chemotherapy-induced peripheral neuropathy (CIPN): a randomized double-blind clinical trial study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201128049515N1
Enrollment
80
Registered
2020-12-17
Start date
2020-12-21
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Chemotherapy induced peripheral neuropathy in confirmed diagnosed cancer patients.. Serum neuropathy

Interventions

Intervention 1: Intervention group: 140 mg/day of silymarin (Gol Daru Company, Iran) in two daily doses with 300 mg/day Gabapentin as a standard treatment for peripheral neuropathy for 3 month. Both m

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Histologically confirmed diagnosis of cancer At least 18 years of age Having chemotherapy-induced peripheral neuropathy (CIPN).

Exclusion criteria

Exclusion criteria: Having a known disease predisposing to neuropathy, including diabetes, neuromuscular disease, vitamin B12 deficiency, amyloidosis, and connective tissue disease, a history of neurological diseases such as hereditary and acquired neuropathies Unbearable side effects of the drug or drug reaction Taking any antioxidant supplement in the last two months Pregnancy, or breastfeeding unwillingness to attend the study

Design outcomes

Primary

MeasureTime frame
Neuropathy intensity. Timepoint: The first day and 3rd month after the onset of the intervention. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAE) criterion and questionnaire.

Secondary

MeasureTime frame
Quality of life. Timepoint: The first day and the 3rd month after the start of the intervention. Method of measurement: European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ).;Pain intensity. Timepoint: The first day and 3rd month after the start of the intervention. Method of measurement: Visual analysis scale (VAS) criterion and questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ramin Shekarriz

Mazandaran University of Medical Sciences

r.shekarriz@mazums.ac.ir+98 11 3336 4044

Outcome results

None listed

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