â??Comparision of Efficacy and Safety of Amitriptyline and Mirtazapine in Peripheral Diabetic Neuropathic Pain: A Randomized,Open Labelled,Parallel Group Studyâ??

Dr Kaksha Patel0 个研究点目标入组 120 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Rating of greater than or equal to 4 on Brief Pain Inventory (BPI) 24 hour average pain item
•Daily pain for greater than 3 months before entry into study
•Stable glycemic control (HbA1c less than or equal to 7)
•Score of atleast greater than or equal to 3 in section B of Michigan Neuropathy Screening
•Patient either of Diabetes 1 or 2
•Ability to give written informed consent

•Risk of suicide as judged by investigator by score greater than or equal to 2 on suicide parameter of Hamilton depression score
•Disorder like mania, bipolar disorder, and psychosis
•Patient with renal dysfunction (serum creatinine greater than 1.2 mg/dl)
•Patient with Vitamin B12 level less than 200ng/L
•Clinically significant cardiovascular, respiratory ,central nervous system, endocrinal or dermatological disorder
•Patient with symptomatic or history of peripheral vascular disease
•Patient with history of alcohol intake
•Patient with allergic reaction to test drug
•Patient with neoplastic disease
•History of substance abuse
•Patient with uncontrolled hypertension
•Patients who were unable to continue for the proposed length of treatment or return for follow-up visits.
•Pregnant or lactating women
•Apparently unresponsive to test drug
•Patient with HIV neuropathy

发起方

Dr Kaksha Patel