drugset / Trial / NCT02155361

Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy

NCT02155361 ↗

Phase 1/2 Completed 70 enrolled Shiraz University of Medical Sciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is designed to evaluate the topical Citrullus colocynthis fruit oil efficacy in treatment of painful peripheral diabetic neuropathy (PDN) in a randomized double blind placebo-controlled clinical trial design. This study includes 60 patients from SUMS endocrinology and diabetes clinic. Patients with painful conditions other than PDN such as radiculopathies will be excluded. After giving the Informed consent the patients will be underwent NCS (Nerve Conduction Study) for confirming the diagnosis before recruitment. They will be followed for 12 weeks and after 12 weeks the outcome measures including Neuropathic Pain Scale (NPS), WHOQOL-BREF (World Health Organisation Quality of Life Brief) questionnaire and electrodiagnostic criteria will be evaluated.

Timeline

Start
2014-06
Primary completion
2014-08
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Citrullus colocynthis fruit oil Unknown 1 % Topical
Comparator Citrullus colocynthis fruit oil Unknown 1 ml Topical

Indications