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IRCT20150825023753N8 IRCT 2018-06-05 Shahid Beheshti University of Medical Sciences Effects of syrup of Jollab on fatigue in patients with breast cancer Study of the effect of syrup of Jollab on cancer-related fatigue in patients with breast cancer: A randomised control trial 2017-11-01 anticipated 60 Complete https://irct.ir/trial/31650 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation software Ink was used to create a randomization table, Blinding description: In order to blind the investigator, medications were named A (syrup of Jollab ) and B (Placebo). The patient was not aware of the type of drug he was assigned to. The groups were also coded A and B to the statistical analyzer. 3 Neoplastic (malignant) related fatigue. Intervention 1: Intervention group: patients with breast cancer-related fatigue receiving syrup of Jollab, 10 cc three times daily for four weeks;. Intervention 2: Control group: patients with breast cancer-related fatigue receiving placebo, 10 cc three times daily for four weeks. Yes - There is a plan to make this available What will be shared: Demographic data and the result of the clinical trial When: 6 month later To whom: Researchers Conditions: After publication of the extracted article of the clinical trial Where to obtain: Sending Email to the researchers How to obtain: Sending the request via the email Comments:
public Dr. Ghazaleh Heydarirad
Shams Alley, Vali-e-Asr Street, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6027 ghazalrad@yahoo.com Shahid Beheshti University of Medical Sciences scientific Dr. Ghazaleh Heydarirad
Shams Alley, Vali-e-Asr Street, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6027 ghazalrad@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Female gender Age between 18- 70 years old Patients known case of breast cancer Hemoglobin level is at least 8 g / dl Hematocrit level at least 30% The level of TSH is normal 18 years 70 years Female Patients known case of heart disease with unstable conditions Disabling Pulmonary Disease and History of Asthma Patients known case of severe kidney disease Creatinine level is greater than 2mg / dl Proteinuria The SGOT level is more than 3 times of the normal threshold Bilirubin levels is greater than 2mg / dl Positive history of hypersensitivity to saffron, Rose water and Honey Uncontrolled pain, severe infection, serious illness Positive history of gout or high level of uric acid An individual who uses antidepressants due to depression Simultaneous use of drugs that affect fatigue Unwillingness to participate in the study Active treatment for anemia (transfusion or Epoetin Alfa Injection) R53.0 Neoplastic (malignant) related fatigue Treatment - Drugs Placebo Intervention group: patients with breast cancer-related fatigue receiving syrup of Jollab, 10 cc three times daily for four weeks; Control group: patients with breast cancer-related fatigue receiving placebo, 10 cc three times daily for four weeks. Score of Fatigue Severity "Visual Analogue Fatigue Scale". Timepoint: The weeks of 0 and 4 after treatment. Method of measurement: Using Visual Analogue Fatigue Scale questionnaire. Score of "Fatigue Severity". Timepoint: The weeks of 0 and 4 after treatment. Method of measurement: Fatigue Severity Scale questionnaire. Score of "The Cancer Fatigue Scale". Timepoint: The weeks of 0 and 4 after treatment. Method of measurement: The Cancer Fatigue Scale questionnaire. Shahid Beheshti University of Medical Sciences Approved 2017-10-29 Ethics Committee on Biomedical Research of Shahid Beheshti University of Medical sciences Shahid Beheshti University of Medical sciences, Daneshju Blv. Tehran Tehran Iran (Islamic Republic of)