A study of Gabapentin and Duloxetine in Painful Diabetic Neuropathy
- Conditions
- Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
- Registration Number
- CTRI/2018/10/015944
- Lead Sponsor
- All India Institute of Medical Sciences Jodhpur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients of either sex with type 2 DM, aged 18 -75 years, who were on stable glucose-lowering medications during the preceding month and who had Painful diabetic neuropathy for at least1 month.
2.Had a pain score of >50%, as assessed by visual analog scale (VAS).
1.If they had any clinically significant or unstable medical or psychiatric illnesses.
2.Patients with other causes of neuropathy.
3.Renal dysfunction; liver disease; epilepsy; psychiatric illness; uncontrolled hypertension; malignancy;
4.Substance abuse; those taking anticonvulsants, antidepressants, local anaesthetics, or opioids;
5.Pregnant; lactating women; or those being treated with any investigational drug within last 30 days.
6.If they had Vitamin B12 level less than 200 pg/ml.
7.Patients with HbA1C levels > 9 %.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of Duloxetine versus Gabapentin in patients with painful diabetic neuropathy in terms of Visual Analogue Scale (VAS).Timepoint: 0, 6, 12 weeks
- Secondary Outcome Measures
Name Time Method To compare the change in diabetic neuropathy symptom (DNS) score, diabetic neuropathy examination (DNE) score and modified neuropathy symptom score (NSS) of Duloxetine versus Gabapentin in patients with painful diabetic neuropathyTimepoint: 0, 6 and 12 weeks;To compare the safety of Duloxetine versus Gabapentin in patients with painful diabetic neuropathy.Timepoint: Throughout the study