Health Condition 1: G64- Other disorders of peripheral nervous system
Conditions
Interventions
Intervention1: Neuroroj: 300 mg capsule taken orally twice a day for 12 weeks
Control Intervention1: placebo: 300 mg capsule taken orally twice a day for 12 weeks
Sponsors
BigBrother Nutra Care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 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.
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropathy Symptom Score â?¢ Diabetic Neuropathy Examination Score â?¢ Vibration perception test and monofilament test â?¢ Visual Analogue scale (VAS) Timepoint: Day 1 Week 2 Week 4 Week 8 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Reduction in pain scores at the end of 12 weeks from baseline using VAS. Efficacy will be graded as follows: a] Improved: Improvement in the symptoms and signs of neuropathy, based on evaluation on Neuropathy Symptom Score (NSS) & Diabetic Neuropathy Examination Score (DNES), at the end of therapy. Timepoint: Day 1 Week 2 Week 4 Week 8 and Week 12 | — |
Countries
India
Contacts
Public ContactDivya C
Bio Agile Therapeutics Pvt. Ltd.
Outcome results
None listed