Evaluation of therapeutic effects of crosina in diabetic neuropathy

Phase 2

• Conditions: Diabetic neuropathy.; Type 2 diabetes mellitus with diabetic neuropathy, unspecified; E11.40

• Registration Number: IRCT20190810044500N8
• Lead Sponsor: Yazd University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Age over 18 years
NIS score of 2 and above, TSS score of 3 and above, and MNSI score of 7 and above
Adequate literacy to understand the study, drug use and possible side effects
A1C hemoglobin level less than 12

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripheral nerve impulses. Timepoint: The beginning of the study and the end of the study. Method of measurement: By electromyographic device.;Total Neuropathy Score. Timepoint: Once every three weeks, up to twelve weeks. Method of measurement: Neurological criteria of subjective and objective aspects of peripheral nerve function.;Lower limb neuropathy. Timepoint: Once every three weeks, up to twelve weeks. Method of measurement: Michigan screening questionnaire, lower limb examinations.;Pain. Timepoint: Once every three weeks, up to twelve weeks. Method of measurement: Visual Analogue Scale.

Secondary Outcome Measures

Name	Time	Method
Depression. Timepoint: Once every three weeks, up to twelve weeks. Method of measurement: Back questionnaire.;Patients' quality of life. Timepoint: Once every three weeks, up to twelve weeks. Method of measurement: EORTC QLQ-C30 questionnaire.