Comparative Evaluation of Effect of Asbi with Methylcobalamin and Pregablin in Diabetic Peripheral Neuropathy

Not yet recruiting

Conditions: Type 2 diabetes mellitus with neurological complications,

Registration Number: CTRI/2023/08/056046

Lead Sponsor: Department of Moalejat Ajmal Khan Tibbiya College And Hospital Aligarh Muslim University Aligarh

Brief Summary: Diabetes Mellitus and its complications have become the most important contemporary and challenging health problem worldwide. It is identified that diabetes is devastating disease that affects every part of the body, associated with both microvascular (retinopathy, nephropathy and neuropathy) and macrovascular complications (stroke, coronary heart disease and peripheral vascular disease. Diabetic neuropathy is one of the most significant microvascular and troublesome complication of diabetes mellitus, leading to great morbidity and mortality, and is imposes a considerable burden on patientâ€™s quality of life and the health care system.

Among diabetic neuropathies, diabetic peripheral neuropathy is the most common form seen in both type 1 and type 2 diabetes mellitus, and it occur 10 times more frequently than other type.

It is triggered by persistent hyperglycaemia which should not be underestimated, because the progress of the disease may lead to foot ulcer, followed by gangrene that may require amputation. The reported prevalence rate of diabetic peripheral neuropathy is 10-25% Unfortunately, current therapies that reduces symptoms of diabetic peripheral neuropathy do not prevent progression of the disease. Therefore, search of safe and effective drugs for its management is quiet necessary. In Unani system of medicine, ***Asbi*** a compound formulation, used for the treatment of *wajaul asab*, may prove useful in this condition but its efficacy has not been evaluated so far, on scientific parameters, particularly for the management of diabetic peripheral neuropathy. Moreover, modern pharmacological treatment have side effects like nausea, vomiting, headache, blurred vision, dizziness, drowsiness, diplopia, tremors, peripheral oedema and xerostomia. Therefore, safer alternative medicine are need of hour.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Clinical Diagnosed Patients of Diabetic Peripheral Neuropathy With Type 2 Diabetes Mellitus Through Toronto Clinical Neuropathy Score.
Fasting Blood Sugar Less than or equal to 150 mg/dl.
HbA1c Less than or equal to 8.
Vibration Perception Test upto Moderate Loss of Vibration Perception Evaluated by Diabetic Risk Profiler.
Washout Period of 20 Days for Patients Who Were Already Taking Any Drug for Neuropathy.
Patient Willing To Participate And Follow The Instructions.

Exclusion Criteria

Patient below 30 Years and Above 60 Years of Age.
Physiological Status: Pregnancy and Lactation.
Pathological Status: Cardiovascular, Renal, Hepatic Diseases and Thyroid Dysfunction.
Complications of Diabetes Other Than Diabetic Peripheral Neuropathy.
Clinically Suspected Case of Neuropathy Other Than Diabetes.
Patient Having Ischemic or Neuropathic Ulcer Alcoholic Patients.
Patients Taking Neurotoxic Drugs.
Uncontrolled Cases of Diabetes Mellitus.
Severe Loss of Vibration Sensation.
Vibration Perception Test Value > 25 Volts.
Patients Who Refuse to Give Written Consent for the Study and Who Failed to Follow up.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Vibration Perception Threshold Value	Assessment of Vibration Perception Threshold through DRP at Initiation of Study (0 Day) and at the end of Study (60 Days). \| 10 Milligram Monofilament Test at Initiation of the Study (0 Day) and at the end of Study (60 Days).
Grade 0 No Loss of Vibration Perception-Complete Improvement	Assessment of Vibration Perception Threshold through DRP at Initiation of Study (0 Day) and at the end of Study (60 Days). \| 10 Milligram Monofilament Test at Initiation of the Study (0 Day) and at the end of Study (60 Days).
Grade 1 Borderline Loss of Vibration Perception-Slight Improvement.	Assessment of Vibration Perception Threshold through DRP at Initiation of Study (0 Day) and at the end of Study (60 Days). \| 10 Milligram Monofilament Test at Initiation of the Study (0 Day) and at the end of Study (60 Days).
Improvement in The Score For 10 Gram Monofilament.	Assessment of Vibration Perception Threshold through DRP at Initiation of Study (0 Day) and at the end of Study (60 Days). \| 10 Milligram Monofilament Test at Initiation of the Study (0 Day) and at the end of Study (60 Days).
Grade 2 Mild Loss of Vibration Perception-Partial Improvement.	Assessment of Vibration Perception Threshold through DRP at Initiation of Study (0 Day) and at the end of Study (60 Days). \| 10 Milligram Monofilament Test at Initiation of the Study (0 Day) and at the end of Study (60 Days).
Grade 3 Moderate Loss Vibration Perception-No Improvement.	Assessment of Vibration Perception Threshold through DRP at Initiation of Study (0 Day) and at the end of Study (60 Days). \| 10 Milligram Monofilament Test at Initiation of the Study (0 Day) and at the end of Study (60 Days).

Secondary Outcome Measures

Name	Time	Method
Improvement in the subjective parameters:	Loss of light touch & temperature sensation

Trial Locations

Locations (1): Department of Moalejat
🇮🇳
Aligarh, UTTAR PRADESH, India
Department of Moalejat
🇮🇳Aligarh, UTTAR PRADESH, India
Dr Tooba Hayat
Principal investigator
7017948219
tooba.hayat.1997@gmail.com