CTRI/2019/04/018678已完成未知
A randomized double blind placebo-controlled clinical trial to evaluate efficacy and safety of the study drug Neuroroj 300 mg in treatment of painful Peripheral Diabetic Neuropathy (PDN) - Peripheral Diabetic Neuropathy
BigBrother Nutra Care Pvt Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Controlled type 1 or 2 diabetes mellitus. Be on stable antidiabetic treatment (insulin, oral agents, or lifestyle) for at least 4 weeks that is not anticipated to change during the course of the study, except if medically required.
- •2.Glucose levels measurement: Have HbA1c <= 11 %.
- •3.Painful Peripheral diabetic neuropathy for more than 3 months Diabetic neuropathy confirmed on the basis of following criteria
- •Diabetic Neuropathy Symptom Score >1 point
- •Diabetic Neuropathy Examination Score >3 point
- •Vibration perception test and monofilament test.
- •4.Males or females 18-65 years of age
- •5.Clinical presentation of peripheral sensory such as burning pain.
- •6.Patients agreeing to the consent on enrolling study and admitting study protocol.
排除标准
- •1.Pregnant and lactating women.
- •2.Known or at high risk of human immunodeficiency virus (HIV) infection
- •3.Patients who have undergone amputations of even one lower limb.
- •4.Any anticipated need for surgery during the study
- •5.Patients presenting with primary cause of neurologic disorders other than diabetes (e.g. alcoholic neuropathy, carpal tunnel syndrome, sequelae of cerebrovascular disease, cauda equina or spinal cord disease and/or diseases related to the peripheral nerves)
- •6.Any malignancy in the past 2 years
- •7.Those on antidepressants, anticonvulsants, opioid, capsaicin, neuroleptics, any other aldose deductase inhibitors, and antioxidants
- •8.Patients on INH any known agent to neuropathy will be excluded.
- •9.Patients with known vitamin B12 deficiency, chronic inflammatory polyneuropathy
- •10.Patient requires any emergency treatment for neuropathy.
- •11.Patients with impaired hepatic or renal function, severe cardiac, gastrointestinal, pulmonary and skin diseases, diabetic foot infection, peripheral vascular disease and other severe diseases.
- •12.Patients presenting with arteriosclerosis obliterans (ankle brachial pressure index of < 0.8)
- •13.Those with hypersensitivity to the study medication
- •14.Those suffering from any physiological or pathological condition as these could alter the results of the study.
- •15.History of substance abuse or dependence within the past year
- •16.Simultaneous participation in another clinical study or if they were receiving other experimental medications for diabetic neuropathy, prostaglandin E1 preparations, or any other medication that affects symptoms of diabetic neuropathy.
- •17.Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.
研究者
相似试验
招募中
3 期
Antibtiotics for Asymptomatic Acute Otitis MediaAcute otitis media without perforationEar - Other ear disordersACTRN12608000424303Menzies School of Health Research300
尚未招募
不适用
Clinical trial of hair vitamin gummies to improve hair and nail healthCTRI/2023/03/050199Mosaic Wellness Pvt Ltd
招募中
3 期
A study in subjects with Symptomatic genetic heart disease comparing sponsors drug Mavacamten with dummy drug.CTRI/2023/10/058870MyoKardia, Inc.
进行中（未招募）
1 期
Study to evaluate efficacy of treatment with sitagliptin on bone parameters in diabetic womeType-2 diabetesMedDRA version: 20.0Level: LLTClassification code 10012594Term: DiabetesSystem Organ Class: 100000004861EUCTR2018-000859-40-ITMBERTO I - POLICLINICO DI ROMA132
进行中（未招募）
不适用
A randomized double blind, placebo-controlled clinical trial to assess the effects of taspoglutide (RO5073031) on cardiovascular outcomes in subjects with inadequately controlled type 2 diabetes and established cardiovascular disease - EMERGE 8EUCTR2009-014986-22-LTF. Hoffmann-La Roche Ltd2,000