Evaluation of the role of a poly-herbal formulation in management of diabetic neuropathy with special reference to prameha upadrava. - DNCT

Dr Kumudini S Sawale0 个研究点目标入组 120 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•Confirmed diagnosis of diabetes mellitus;
•BSL fasting less than 140 mg/dl, glycosylated hemoglobin below 7) with oral glucose-lowering agents and /or insulin;
•Patients with clinical signs and symptoms of diabetic neuropathy with one or more than one nerve involved.
•Patients with impaired nerve conduction studies of one or more than one peripheral nerve
•Patient does not require any emergency treatment for neuropathy.
•Blood pressure below or equal to 160/90 mmHg at both Screening and Baseline. In addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to Screening, with no more than 1 blood pressure reading not more than 160/90 mmHg

•Any neurological condition requiring urgent medical or surgical intervention
•Any other serious systemic disease within the last 3 months;
•With obvious symptoms or signs of liver diseases, ALT or AST more than two times normal upper limit;
•Severe edema or serous cavity effusion
•Suffering from any malignancy.
•Receiving the long-term systematic steroid, hormone treatment
•Gestation already, prepares to be pregnant in the period of the trial, lactating women;
•Participate in other product clinical trial within 30 days prior to this trial.
•History of previous kidney transplant
•Patients of autonomic neuropathy

发起方

Dr Kumudini S Sawale