The effects of nano curcumin in diabetic peripheral neuropathy

Phase 3

Conditions: Diabetes mellitus.
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
E08.40

Registration Number: IRCT20210925052566N2

Lead Sponsor: ational Institute for Medical Research Development

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 100

Inclusion Criteria

Patients will eligible for recruitment with a MNSI of 2 or higher, abnormal NCS results and normal folate, vitamin B12 levels.

Exclusion Criteria

Exclusion criteria will be uncontrolled diabetes (HbA1c>8.5%), current pregnancy or lactating women, alcohol intake, current smoker, diabetic foot , mental disease, heart failure, cancer, evidence of liver disease (such as viral hepatitis, autoimmune hepatitis, etc.), impaired renal (GFR < 30), sensitivity to turmeric supplementation, current use of warfarin or other anticoagulant agents, and those with symptomatic peripheral vascular disease.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Michigan neuropathy screening instrument (MNSI). Timepoint: Baseline and 16 weeks. Method of measurement: Using standard scoring systems and questionnaires. Scoring is: Michigan neuropathy screening instrument , (0-10).;Neuropathy disability score (NDS). Timepoint: Baseline and 16 weeks. Method of measurement: Using standard scoring systems and questionnaires. Scoring is: Neuropathy disability score (0-10).

Secondary Outcome Measures

Name	Time	Method
Pain score. Timepoint: Baseline and 16 weeks. Method of measurement: Patients will be asked to score pain on a visual analog scale 0-10 with 10 being the worst pain ever.;Fasting glucose, serum insulin, HOMA –IR, and HBA1c. Timepoint: Baseline and 16 weeks. Method of measurement: lab kit.;Lipid profiles (HDL-c, LDL-c, TG, TC). Timepoint: Baseline and 16 weeks. Method of measurement: lab kit.