]>
IRCT20180130038565N1 IRCT 2018-02-19 Zanjan University of Medical Sciences Biebersteinia Multifida root in systolic heart failure Clinical trial of the effect of “Biebersteinia Multifida root” on quality of life in patients with systolic heart failure 2018-03-01 anticipated 60 Complete https://irct.ir/trial/29338 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: By using random numbers table, patients are divided in two 30 person case-control groups, Blinding description: 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. 3 Systolic heart failure. Intervention 1: Intervention group: Dry extract of Biebersteinia Multifida root with a concentration of 10 percent relative to 100 g of roots of the plant, has been standardized 250 mg per capsule at the school of Pharmacy of Shahid Beheshti University of Medical Sciences. The drug is given one capsule every 12 hours for 60 days to volunteer patients with systolic heart failure who have ejection fraction equal to or less than 40 percent. Intervention 2: Control group: Placebo in the control group contains starch corn which is provided in capsules and boxes of the same intervention group at the school of Pharmacy of Shahid Beheshti University of Medical Sciences. The placebo is given one capsule every 12 hours for 60 days to volunteer patients with heart failure who have ejection fraction equal to or less than 40 percent. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Ebadollah Salekmoghadam
Education and Treatment Center of Valiasr, Valiasr sq.
Zanjan Iran (Islamic Republic of) 4515777978 +98 24 3377 0801 salekmoghadam@zums.ac.ir Zanjan University of Medical Sciences scientific Hassan Ahangar
Special clinic of cardiovascular disease of Zanjan University of Medical Sciences, Amin doctors' building, Haft tir st.
Zanjan Iran (Islamic Republic of) 4518617384 +98 24 3356 5333 ahanghar@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) 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 40 years 75 years Both 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 I50.2 Systolic (congestive) heart failure Treatment - Drugs Placebo Intervention group: Dry extract of Biebersteinia Multifida root with a concentration of 10 percent relative to 100 g of roots of the plant, has been standardized 250 mg per capsule at the school of Pharmacy of Shahid Beheshti University of Medical Sciences. The drug is given one capsule every 12 hours for 60 days to volunteer patients with systolic heart failure who have ejection fraction equal to or less than 40 percent. Control group: Placebo in the control group contains starch corn which is provided in capsules and boxes of the same intervention group at the school of Pharmacy of Shahid Beheshti University of Medical Sciences. The placebo is given one capsule every 12 hours for 60 days to volunteer patients with heart failure who have ejection fraction equal to or less than 40 percent. Quality of Life Score in the Minnesota Questionnaire. Timepoint: Measure the quality of life score at the beginning of study (before intervention) and one week after taking the Biebersteinia Multifida root extract. Method of measurement: Minnesota Living With Heart Failure Questionnaire. The distance traveled in six minute walk test. Timepoint: Measure the distance traveled in six minute walk test at the beginning of study (before intervention) and one week after taking the Biebersteinia Multifida root extract. Method of measurement: Six minute walk test. Left ventricular ejection fraction. Timepoint: Measurement of left ventricular ejection fraction at the beginning of study (before intervention). Method of measurement: Echocardiography. Complete blood count. Timepoint: Measurement of complete blood count at the beginning of study (before intervention) and one week after taking the Biebersteinia Multifida Root Extract. Method of measurement: Blood test. Blood urea nitrogen. Timepoint: Measurement of blood urea nitrogen at the beginning of study (before intervention) and one week after taking the Biebersteinia Multifida Root Extract. Method of measurement: Blood test. Serum creatinine. Timepoint: Measurement of serum creatinine at the beginning of study (before intervention) and one week after taking the Biebersteinia Multifida Root Extract. Method of measurement: Blood test. Alanine aminotransferase. Timepoint: Measurement of Alanine aminotransferase at the beginning of study (before intervention) and one week after taking the Biebersteinia Multifida Root Extract. Method of measurement: Blood test. Aspartate aminotransferase. Timepoint: Measurement of Aspartate aminotransferase at the beginning of study (before intervention) and one week after taking the Biebersteinia Multifida Root Extract. Method of measurement: Blood test. Alkaline phosphatase. Timepoint: Measurement of Alkaline phosphatase at the beginning of study (before intervention) and one week after taking the Biebersteinia Multifida Root Extract. Method of measurement: Blood test. C-reactive protein. Timepoint: Measurement of C-reactive protein at the beginning of study (before intervention) and one week after taking the Biebersteinia Multifida Root Extract. Method of measurement: Blood test. Zanjan University of Medical Sciences Approved 2018-01-23 Ethics committee of Zanjan University of Medical Sciences Ethics committee, Zanjan University of Medical Sciences, Azadi sq., Jomhouri Islami Ave. Zanjan Zanjan Iran (Islamic Republic of)