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IRCT20230926059519N1 IRCT 2023-10-10 Kermanshah University of Medical Sciences Investigating the effect of the Tribulus terrestris, Platanus leaves and Medicago sativa in thrombocytopenia Investigating the effect of the combination of hydroalcoholic extracts of Tribulus terrestris, Platanus leaves and Medicago sativa on increasing production of platelets and other blood products in patients with thrombocytopenia: A Randomized Double-Blind Clinical Trial 2023-10-07 anticipated 40 Complete https://irct.ir/trial/72781 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method will be used using blocks of 4. A third person who is not involved in the process of taking patients and evaluating patients will create a random sequence using the site: https://www.sealedenvelope.com and based on the sample size, 10 blocks of 4 will be created. Each patient will be given a unique code that can be created on this site. Therefore, concealment is observed and the people involved in the study do not know in which group the next person will be placed and they will not know about the random sequence and only the statistics consultant will know about the random sequence and the codes will remain with them. The study is double-blind and the drugs are prepared in identical containers, and none of the patients and the person who evaluates the patients will know what drug was received. Medicines are sealed and an arrangement will be adopted that only people of one group will visit on that day during the re-evaluation and this work will be planned by the statistics consultant who knows about the codes, Blinding description: The study is double-blind and the drugs and placebo are prepared in identical containers, and none of the patients and the person who evaluates the patients will know what drug was received. Medicines are sealed and an arrangement will be adopted that only people of one group will visit on that day during the re-evaluation and this work will be planned by the statistics consultant who knows about the codes. 3 Thrombocytopenia. Intervention 1: Intervention group: The drug is taken by the patient in the form of 500 mg tablets 3 times a day (1.5 grams per day) for 7 days. The drug is a new product of Karzan DaruDarman Company and it is composed of hydroalcoholic extract from each plant in the ratio of 70:20:10 (70% Tribulus terrestris, 20% Platanus leaves, 10% Medicago sativa). Intervention 2: Control group: The drug is given to the patients in the form of tablets with the same weight as the main drug and 3 times a day for 7 days. 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 Mehrdad Payandeh
Imam Reza Hospital, Next to the Faculty of Medicine, The end of the nurse blvd, Kermanshah
Kermanshah Iran (Islamic Republic of) 6742775333 +98 83 3427 6300 m_payandeh@kums.ac.ir Kermanshah University of Medical Sciences scientific Mehrdad Payandeh
Imam Reza Hospital, Next to the Faculty of Medicine, The end of the nurse blvd, Kermanshah
Kermanshah Iran (Islamic Republic of) 6742775333 +98 83 3427 6300 m_payandeh@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of the patient Age between 18 and 75 years Platelet count test below 150 thousand No spontaneous bleeding No pregnancy Completing the informed consent form 18 years 75 years Both - Reduction of platelets below 10,000 and the need for hospitalization Active bleeding D69.6 Thrombocytopenia, unspecified Treatment - Drugs Placebo Intervention group: The drug is taken by the patient in the form of 500 mg tablets 3 times a day (1.5 grams per day) for 7 days. The drug is a new product of Karzan DaruDarman Company and it is composed of hydroalcoholic extract from each plant in the ratio of 70:20:10 (70% Tribulus terrestris, 20% Platanus leaves, 10% Medicago sativa). Control group: The drug is given to the patients in the form of tablets with the same weight as the main drug and 3 times a day for 7 days. Platelet. Timepoint: The beginning of the study and 7 days later. Method of measurement: Blood test. White blood cells. Timepoint: The beginning of the study and 7 days later. Method of measurement: Complete Blood Count test. Red blood cells. Timepoint: The beginning of the study and 7 days later. Method of measurement: Complete Blood Count test. Hemoglobin. Timepoint: The beginning of the study and 7 days later. Method of measurement: Complete Blood Count test. Neutrophil. Timepoint: The beginning of the study and 7 days later. Method of measurement: Complete Blood Count test. Lymphocyte. Timepoint: The beginning of the study and 7 days later. Method of measurement: Complete Blood Count test. Eosinophil. Timepoint: The beginning of the study and 7 days later. Method of measurement: Complete Blood Count test. Monocyte. Timepoint: The beginning of the study and 7 days later. Method of measurement: Complete Blood Count test. Kermanshah University of Medical Sciences Approved 2023-09-03 Research Ethics Committees of School of Medicine-Kermanshah University of Medical Sciences Faculty of Medicine, University Street, Shahid Shiroudi Boulevard, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)