Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial of the Effect of Neurotec in Symptomatic Diabetic Neuropathy

ParsRoos Company0 个研究点目标入组 300 人开始时间: 待定最近更新: 2018年2月22日

适应症

试验速览

暂无简介。

•Inclusion Criteria:
•Pain equivalent to 4 or more on a numerical scale between 0 and 10, Diagnosis of Diabetes Mellitus (Type 1 or 2) defined by American Diabetes Association criteria for at least 3 years, Haemoglobin A1C less than 10%, History of Diabetic Neuropathy for more than a year, Age more than 18 years and less than 60, diagnosis of neuropathy based on Michigan Neuropathy Screening Instrument

•Presence of uncontrolled or poor controlled DM, Presence of neuropathy due to other causes than DM, Receiving any investigational drug within 30 days prior to screening, Presence of active or infected diabetic wound, Amputation, Presence of any other systemic or chronic diseases such as: Myopathy, Vasculitis, Peripheral Vascular Diseases, Chronic hepatic or renal diseases, clinically complicating pulmonary, Cardiac, Hematologic, Gastrointestinal, Endocrine disease or Malignancy, Symptomatic degenerative joint disease, active radiculopathy or discopathy, spinal stenosis , active degenerative disc diseases, chronic sciatalgia, sacroiliac joint dysfunction or any chronic painful condition involving lower extremities, apparent or diagnosed psychological problem such as anxiety or depression, Diabetic Retinopathy or retinal haemorrhage, Pregnancy or intention of becoming pregnant during the study period (9 months), Inability to give informed consent according to the agreed process, Corticosteroid therapy, Any drug hypersensitivity, Radiotherapy, Chemotherapy or any immuosuppressive drug use, Electrolyte imbalance

发起方

ParsRoos Company