The comparative study of combination Gabapentin and topiramate vs treatment alone topiramate or Gabapentin of painful diabetic neuropathy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201108287432N1

Enrollment

150

Registered

2012-01-12

Start date

2011-11-16

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Diabetic neuropathy. Insulin-dependent diabetes mellitus with neurological complications

Interventions

Intervention 1: In second group, gabapentin started by 300 mg/daily and like the first groups are examined. Intervention 2: In first group, treatment started with 50mg/daily topiramate and patients vi

Treatment - Drugs

In second group, gabapentin started by 300 mg/daily and like the first groups are examined.

In first group, treatment started with 50mg/daily topiramate and patients visited respectively at day 15, 30, 60 and 90 and drug dose increases based on treatment response and patient tolerance if nec

The third group combination of 25mg topiramate and 100mg gabapentin will start and on the basis of response to treatment and patient tolerance the dose will increased

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria included: 1 - diabetes Type II 2 - Dissatisfaction at entering the study, 3 - Failure to receive medication to control pain when the study began, 4 - exposure to neuropathic pain from diabetes. Exclusion criteria: kidney disease - pregnancy - breastfeeding - a history of liver disease - while taking anti-seizure- taking OCP - a history of sensitivity to Astazvlamydya - other causes for neuropathy, such as MS-CVA

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Improvement of painful diabetic neuropathy. Timepoint: Day 15, 30, 60 and 90. Method of measurement: Based on TCSS.	—

Secondary

Measure	Time frame
Changes in HbA1c. Timepoint: Day 15, 30, 60, 90. Method of measurement: Based on laboratory assessment.;Changes in triglycerid. Timepoint: Day 15, 30, 60, 90. Method of measurement: based on laboratory assessment.;Changes in cholestrol. Timepoint: Day 15, 30, 60, 90. Method of measurement: based on laboratory assessment.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. MehrAli rahimi

Kermanshah University of Medical Sciences

m.javadra@yahoo.comm.javadra@kums.ac.ir+98 83 1427 6314

Outcome results

None listed

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