Health Condition 1: null- Patients known case of Diabetes Mellitus with diabetic neuropathy
Conditions
Interventions
Intervention1: Poly-herbal capsule: Poly-herbal capsule
1500 mg BD Orally for 6 months
Control Intervention1: Gabapentin
: Gabapentine
75 mg TDS for 6 months
Sponsors
Dr Kumudini S Sawale
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 Drug abuse 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of functions of peripheral nervesTimepoint: Improvement of functions of peripheral nerves | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the clinical signs and symptoms of Diabetic neuropathy Improvement in the nerve conduction velocityTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactKumudini Sukadev Sawale
Ayurved Seva Sanghs Ayurved Mahavidyalaya Nashik
Outcome results
None listed