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IRCT20180130038563N1 IRCT 2018-02-21 Zanjan University of Medical Sciences Effect of Centaurea behen Root in Systolic Heart Failure Clinical Trial of the Centaurea behen Root Effect on Quality of Life in Patients with Systolic Heart Failure 2018-03-01 anticipated 60 Complete https://irct.ir/trial/29273 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: By using random number table, patients are divided into two 30 patients intervention-control groups, Blinding description: All participants and researcher are blind in this study, coding of drug and placebo are under the responsibility of the statistical adviser who is not blind. 3 Systolic heart failure. Intervention 1: Intervention group: A Centaurea behen root extract, with a concentration of 20 percent from plant root and as capsules with a dose of 150 milligrams of dried extract that has been standardized based on total phenol, has been made in the Pharmacognosy Department of the Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences. With two-way blindness being observed, the 30 patients in the intervention group, are given a capsule for two months and every 12 hours. Intervention 2: Control group: The placebo used in this study is made of corn starch and in terms of its appearance and type of packaging, it is similar to the main drug. It has been made in Pharmacognosy department of Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences. With two-way blindness being observed, the 30 patients, In the control group, are given a capsule for two months and every 12 hours. 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 There is no more data
public Saeid Yousefi
Education and Treatment Center of Valiasr, Valiasr sq.
Zanjan Iran (Islamic Republic of) 4515777978 +98 24 3377 0801 sayusefi@zums.ac.ir Zanjan University of Medical Sciences scientific Hassan Ahangar
Special Clinic of Cardiovascular Diseases of Zanjan University of Medical Sciences, Amin Doctor's 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 study participation Age 40 to 75 Systolic heart failure with ejection fraction equal or lesser than 40 percent Currently taking heart medications, prescribed by cardiologist 40 years 75 years Both Pregnancy Breast feeding Allergy to Centaurea behen root extract Patient's unwillingness to continue participation Chronic inflammatory disease Severe renal failure Collagen vascular disease Severe liver disease Acute infectious disease Malignancy Decompensated heart failure I50.2 Systolic (congestive) heart failure Treatment - Drugs Placebo Intervention group: A Centaurea behen root extract, with a concentration of 20 percent from plant root and as capsules with a dose of 150 milligrams of dried extract that has been standardized based on total phenol, has been made in the Pharmacognosy Department of the Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences. With two-way blindness being observed, the 30 patients in the intervention group, are given a capsule for two months and every 12 hours. Control group: The placebo used in this study is made of corn starch and in terms of its appearance and type of packaging, it is similar to the main drug. It has been made in Pharmacognosy department of Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences. With two-way blindness being observed, the 30 patients, In the control group, are given a capsule for two months and every 12 hours. The Quality of Life Score in the Minnesota Questionnaire. Timepoint: At the beginning of the study (before intervention) and one week after the end of the Centaurea behen Root Extract taking. Method of measurement: The Minnesota Living with Heart Failure Questionnaire. The Distance traveled in The Six Minute Walk Test. Timepoint: At the beginning of the study (before intervention) and one week after the end of the Centaurea behen Root Extract taking. Method of measurement: The Six Minute Walk Test. The Left Ventricular Ejection Fraction. Timepoint: At the beginning of the study (before intervention). Method of measurement: Echocardiography. Complete blood count. Timepoint: At the beginning of the study (before intervention) and one week after the end of the Centaurea behen Root Extract taking. Method of measurement: Blood test. Blood urea nitrogen. Timepoint: At the beginning of the study (before intervention) and one week after the end of the Centaurea behen Root Extract taking. Method of measurement: Blood test. C-reactive protein. Timepoint: At the beginning of the study (before intervention) and one week after the end of the Centaurea behen Root Extract taking. Method of measurement: Blood test. Serum creatinine. Timepoint: At the beginning of the study (before intervention) and one week after the end of the Centaurea behen Root Extract taking. Method of measurement: Blood test. Aspartate aminotransferase. Timepoint: At the beginning of the study (before intervention) and one week after the end of the Centaurea behen Root Extract taking. Method of measurement: Blood test. Alanine aminotransferase. Timepoint: At the beginning of the study (before intervention) and one week after the end of the Centaurea behen Root Extract taking. Method of measurement: Blood test. Alkaline phosphatase. Timepoint: At the beginning of the study (before intervention) and one week after the end of the Centaurea behen Root Extract taking. 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 Univerisity of Medical Sciences, Azadi sq., Jomhouri Islami Ave. Zanjan Zanjan Iran (Islamic Republic of)