Clinical trial of the effect of “Biebersteinia Multifida root” on quality of life in patients with systolic heart failure

Evaluation of the effect of Biebersteinia Multifida root extract on quality of life in patients with systolic heart failure

This study is a randomized, double-blind clinical trial with parallel groups in which 60 patients are randomly divided into two case-control groups

Sixty patients with systolic heart failure were selected in the special cardiovascular clinic of Zanjan University of Medical Sciences and randomly divided into two equal groups of 30 people. Patients in the intervention and control groups receive 250 mg of Biebersteinia Multifida root extract and placebo per capsule every 12 hours, respectively. During the study, patients are examined every two weeks. Participants and researcher are blind and not a blind statistic consultant

Inclusion criteria: Informed consent to participate in the study, Age 40 to 75, Systolic heart failure with ejection fraction equal or lesser than 40 percent, Continuing heart medications prescribed by cardiologist. Exclusion criteria: Pregnancy, Breast feeding, Malignancy, Allergy to Biebersteinia Multifida root extract, Unwillingness of the patient to continue cooperation, Chronic inflammatory disease, Severe renal failure, Collagen vascular disease, Severe liver disease, Acute infectious disease, Decompensated heart failure

Biebersteinia Multifida root extract: Each patient in the intervention group takes a capsule for two months and every twelve hours Placebo: Each patient in the intervention group takes a capsule for two months and every 12 hours

Quality of life score in the Minnesota Questionnaire; The distance traveled in six minute walk test.

By using random numbers table, patients are divided in two 30 person case-control groups

All participants and researchers are blind in this study ,coding of medicine and placebo are under the responsibility of a statistical adviser who is not blind