Health Condition 1: I739- Peripheral vascular disease, unspecified
Conditions
Interventions
Intervention1: Nicorandil: Intervention arm- Nicorandil 10 mg BD for 30 days
Control Intervention1: Placebo: Comparator arm- Matched placebo BD for 40 days
Sponsors
All India Institute of Medical Sciences Rishikesh
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To study efficacy of Nicorandil on Pain Free Walking Distance (PFWD) Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Peripheral Arterial Questionnaire (PAQ) from baseline values in each group 2. Change in the ankle brachial index (ABI) with respect to baseline values 3. Change in the ankle systolic pressure (ASP) with respect to baseline values 4. Change in subjective claudication distance (SCD) reported by the patient 5. Additional analgesic requirement during the course of study 6. Change in Vitamin D levels with respect to baseline values Occurrence of Adverse events during the study Timepoint: 0, 7, 28 days | — |
Countries
India
Contacts
Public ContactRaja Lahiri
AIIMS RIshikesh
Outcome results
None listed