A clinical trial to study the effects of two drugs, Poly-herbal capsules and Pregabelin in patients of diabetes mellitus with diabetic neuropathy.
- Conditions
- Health Condition 1: null- Patients known case of Diabetes Mellitus with diabetic neuropathy
- Registration Number
- CTRI/2016/01/006533
- Lead Sponsor
- Dr Kumudini S Sawale
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of functions of peripheral nervesTimepoint: Improvement of functions of peripheral nerves
- Secondary Outcome Measures
Name Time Method Improvement in the clinical signs and symptoms of Diabetic neuropathy <br/ ><br>Improvement in the nerve conduction velocityTimepoint: 6 months