Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases Health Condition 2: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Controlled Type 2 Diabetes mellitus i.e., stable on Oral Hypoglycemic Agents or insulin. 2)HbA1c 3)Diabetic patient with clinical presentation of peripheral neuropathy. 4)Patients having DPN on the basis of Diabetic Neuropathy Symptom (DNS) score >=1, Diabetic Neuropathy Examination (DNE) score >= 3, abnormal monofilament test and abnormal VPT. 5)BP 6)Patients willing for inclusion in clinical trial.
Exclusion criteria
Exclusion criteria: 1)Any neurological condition requiring urgent medical intervention. 2)Any other serious systemic disease in last 3 months. 3)Patients having malignancies, serious infections as well as those requiring long term steroids and hormonal treatment. 4)Pregnant and lactating women. 5)Patients having H/O renal transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Reduction in symptoms of Diabetic Peripheral Neuropathy. 2)Improvement in scores of TCSS. Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Improvement in VPT demonstrated using a biothesiometer. 2)Improvement in the visual analogue scale. 3)Improvement in HbA1c.Timepoint: 3 months | — |
Countries
India
Contacts
Bharati Vidyapeeth (Deemed to be University)