Effect of the drug Nicorandil in Peripheral Vascular Disease
Phase 2
- Conditions
- Health Condition 1: I739- Peripheral vascular disease, unspecified
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Newly diagnosed patients with intermittent claudication (according to Edinburgâ??s Claudication Questionnaire1 )- suggestive of Peripheral vascular disease
2.Patients already diagnosed as case of Peripheral vascular disease with clinical and radiological evidence suggestive of chronic limb ischemia/ PVD
3.Age > 18 years to 65 years
4.Pain involving either single limb or both lower limbs
Exclusion Criteria
1.Acute limb ischemia
2.Acute on chronic limb ischemia
3.Patients with connective tissues disorders with vasculitis
4.Have a neurological condition other than that associated with their pain diagnosis which, in the opinion of the investigator, would interfere with their ability to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To study efficacy of Nicorandil on Pain Free Walking Distance (PFWD) <br/ ><br>Timepoint: 4 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Change in Peripheral Arterial Questionnaire (PAQ) from baseline values in each group <br/ ><br>2.Change in the ankle brachial index (ABI) with respect to baseline values <br/ ><br>3.Change in the ankle systolic pressure (ASP) with respect to baseline values <br/ ><br>4.Change in subjective claudication distance (SCD) reported by the patient <br/ ><br>5.Additional analgesic requirement during the course of study <br/ ><br>6.Change in Vitamin D levels with respect to baseline values <br/ ><br>Occurrence of Adverse events during the study <br/ ><br>Timepoint: 0, 7, 28 days