Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT05292066
Eligibility Criteria:
Inclusion Criteria:
* Both male and female patient with age more than 18 years to 70 years.
* Patients diagnosed with peripheral neuropathic pain affected by diabetes from at least 24 weeks and all other causes off peripheral painful neuropathy has been already excluded by their primary physician.
* Patients who may agree with written inform consent.
* HbA1c ≥ 6.5% and ≤ 10%
Exclusion Criteria:
* Patients with severe hepatic disease, cardiovascular diseases, Epilepsy and respiratory diseases or any other medical or psychiatric disorders.
* Patients with uncontrolled hypertension.
* DM patients with foot ulcers, foot injuries or any other painful lesion.
* Patients who are already using or used duloxetine or pregabalin in last three month.
* Pregnant women or those who may not agree to use medical recommended birth control procedures during the treatment.
* Patient with thyroid known disorders or diagnosed during the screening
* Vitamin B12 deficient patient
* Chronic alcoholics
* DKD, with eGFR \< 30ml/min
* Hypertriglycedmia (TGs more then 250mg/dl)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05292066
Study Brief:
Protocol Section:
NCT05292066