The applicant's goals for this MMSCRP are to obtain an in-depth exposure to academic clinical research and to begin to acquire the skills necessary for a career in patient- oriented research. In addition, the specific project to be investigated will allow the applicant to apply rigorous scientific methods in the study of a complementary medical therapy for a clinical problem which does not respond well to conventional therapies. The applicant will receive structured mentoring at all stages of the study, including recruitment of patients, performance of study tests, data organization, analysis, interpretation, and presentation. The applicant's educational plan will provide rigorous coursework in a one-year program which will cover outcomes research and clinical epidemiology, study design, biostatistical methods and analysis, conduct of clinical trials, ethical issues in clinical trials, and health services research. In addition to formal coursework, the applicant will actively participate in protocol review and discussions in the University's Institutional Review Board. Finally, the applicant will fully participate in regularly scheduled conferences, meetings, and reviews of protocols in the General Clinical Research Center (GCRC). The clinical study will be a prospective, randomized, double-blind, placebo-controlled trial to determine if a herbal preparation, Padma Basic, improves function in patients with symptomatic PVOD treated for 16 weeks. The primary endpoint of the study is maximal walking distance. Secondary endpoints will include: 1) pain-free walking distance; 2) flow-mediated endothelium-dependent forearm vasodilation; 3) resting and post-exercise ankle/brachial indices and arterial waveforms; 4) blood pressure, serum lipid and coagulation profiles; and 5) patient well- being and quality of life self-assessment of function as determined by SF-36 and Walking Impairment Questionnaires. The MMSCRP would provide the applicant with the opportunity to combine an extensive classroom and seminar curriculum in clinical research with a project initiated by the student, in which she will have direct experience in all phases of the conduct of a clinical study including study design, data acquisition, analysis, and presentation. It is expected that this will consolidate information and skills acquired in previous training and will be the first step in a career in patient-based investigation.
