Health Condition 1: E134- Other specified diabetes mellituswith neurological complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Documented Diagnosed cases of Type 1 or 2 diabetes Patients of either sex Patients older than 20 years and less than 60 years of age Stable glycemic control for 3 months i.e. HbA1c DSPN defined by: Bilateral reduced or absent reflexes at the ankles Bilateral impaired vibration, pinprick, fine touch or temperature perception in the distal lower extremities. Persistent distal burning or dull pain in the feet Persistent proximal aching pain in the legs Paroxysmal electric, shooting, stabbing pain Dysasthesias
Exclusion criteria
Exclusion criteria: Patient less than 20 years and more than 60 years Physiological state as pregnancy and lactation. Patients having abnormal blood urea, serum creatinine, SGOT, SGPT. Other causes of neuropathy or lower extremity pain Uncontrolled hypertension at screen (sitting systolic >160 mmHg and/or sitting diastolic >90 mmHg Currently participating in another clinical study in which the subject is, or will be exposed to an investigational or non-investigational drug or device. Pathological state such as cardiovascular diseases, renal diseases, hepatic diseases, peripheral arterial diseases. Unwillingness or inability to comply the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in â?¢ Vibration perception threshold â?¢ Michigan neuropathy screening instrument â?¢ Chronic Acquired Polyneuropathy Patient-Reported Index (CAPPRI) scales Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Dept of Ilaj bit tadbeer National Institute of Unani Medicine Kottigepalya Bangalore