Health Condition 1: G63- Polyneuropathy in diseases classified elsewhere
Conditions
Interventions
Intervention1: Tablet Asbi: Dose: 500 mg
Frequency: Twice a day
Route of administration: Oral
Total duration of the treatment: 45 days
Control Intervention1: Capsule Pregabalin and Methylcobalamin: Do
Sponsors
Central Council for Research in Unani Medicine Ministry of Ayush Govt. of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender between 35-65 years of age. 2. Diagnose cases of Type 2 Diabetes with symptoms of foot discomfort, burning, numbness, and tingling sensation. 3. Patients with a diagnosis of painful diabetic peripheral neuropathy caused by type 2 diabetes mellitus. 4. Patients with peripheral neuropathy caused by hypertension and nutritional deficiencies. 5. Patients whose average pain intensity in painful diabetic peripheral neuropathy in the last 24 hours evaluated at baseline visit is equal or more than 40 mm. 6. Stable treatment of diabetes for at least 3 months with no anticipated changes in medication regimen. 7. Meets the Toronto Criteria for probable clinical sensorimotor polyneuropathy. 8. The presence of any neuropathic symptoms on the "Douleur Neuropathique en 4 Questions. 9. A score of at least 4 on the Douleur Neuropathique en 4 Questions. 10. Patients who will be willing to abide the guidelines of the protocol and instructions of the physicians.
Exclusion criteria
Exclusion criteria: 1. Age below 35 and above 65 years 2. Cases of neuropathy with foot ulcers, and patients with any other systemic or associated diseases as well as poor compliance. 3. Peripheral neuropathy caused by a condition other than diabetes, hypertension, and nutritional deficiencies and or a known history of significant risk factors for neuropathy other than diabetes, hypertension and nutritional deficiencies. 4. Other significant pain conditions involving the same area as the neuropathy. 5. Other pain conditions not involving the same area as the neuropathy which interfere with the participants ability to rate the neuropathy pain 6. Any amputation of the lower limb, or current or previous foot ulcer 7. Significant peripheral vascular disease defined as symptoms consistent with intermittent claudication 8. Not taking medicine and participating in another clinical trial at the same time 9. Alcohol or drug addiction 10. Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain, Numbness, Temperature sensitivity, Muscle cramps, FatigueTimepoint: 0, 15th, 30th, 45th day | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Athar Parvez Ansari
Regional Research Institute of Unani Medicine Chennai CCRUM Ministry of Ayush Govt. of India
Outcome results
None listed