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IRCT20190120042436N4 IRCT 2022-07-09 Yasouj University of Medical Sciences The effect of Achillea Wihelmsii C.Koch on nausea and vomiting and quality of life Comparison of the effect of hydroalcoholic extract of (Achillea Wihelmsii C.Koch) and routine treatment on chemotherapy-induced nausea and vomiting and quality of life in children aged 8-18 years with cancer 2022-07-22 anticipated 40 Complete https://irct.ir/trial/64463 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block method will be used to assign people to the studied groups. Random allocation by block method is for the purpose that exactly equal number of patients enter the intervention and control groups in consecutive time intervals. Groups are formed as A, B, C. To avoid the predictable risk of assigning people to different groups, blocks with different sizes will be created. Before assigning people to one of the groups, a list of letters (A, B, C), i.e. blocks with sizes 3, 9 and 12, is formed by the reliable website https://www.sealedenvelope.com. Based on the order of coming to clinic, the children will be placed in one of the groups and this sampling will continue until the estimated sample size is reached in each group, Blinding description: The drug (Achillea Wihelmsii C.Koch extract) and placebo are prepared in capsules of the same color by a pharmacist and are coded by the pharmacist without the prescriber and the patient being aware of the type of drug (placebo or plant extract). 2-3 Condition 1: nausea and vomiting. Condition 2: cancer. Intervention 1: Intervention group: In addition to receiving routine drugs to control nausea and vomiting caused by chemotherapy, the intervention group will receive two oral capsules containing 150 mg of Achillea wilhelmsii plant extract daily for one week. These capsules are made in the pharmacology department of medicinal plants of Yasouj University of Medical Sciences. Intervention 2: Control group: In addition to receiving routine drugs to control nausea and vomiting caused by chemotherapy, the control group will receive two placebo capsules daily for one week. Each placebo capsule contains 150 mg of starch. These capsules are made in the pharmacology department of medicinal plants of Yasouj University of Medical Sciences. 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 Mohsen Salari
Nursing Faculty, Educational Campus of Yasuj University of Medical Sciences, Dr. Shahid Jalil St.
Yasuj Iran (Islamic Republic of) 75919-94799 +98 74 3323 4115 salarimo@yums.ac.ir Yasouj University of Medical Sciences scientific Mohsen Salari
Nursing Faculty, Educational Campus of Yasuj University of Medical Sciences, Dr. Shahid Jalil St.
Yasuj Iran (Islamic Republic of) 75919-94799 +98 74 3323 4115 salarimo@yums.ac.ir Yasouj University of Medical Sciences Iran (Islamic Republic of) Age 18-8 years Having the informed consent of the children under study and legal guardian Diagnosed with cancer Having nausea and vomiting Treated with chemotherapy drugs Having at least one course of chemotherapy before the intervention Normal hematological and biochemical laboratory values of blood 8 years 18 years Both Gastrointestinal diseases and cancers related to the gastrointestinal tract at the discretion of a fellow physician History of allergy to medicinal plants of the Achilleas family R11 C00-C97 Nausea and vomiting Malignant neoplasms Treatment - Drugs Other Intervention group: In addition to receiving routine drugs to control nausea and vomiting caused by chemotherapy, the intervention group will receive two oral capsules containing 150 mg of Achillea wilhelmsii plant extract daily for one week. These capsules are made in the pharmacology department of medicinal plants of Yasouj University of Medical Sciences. Control group: In addition to receiving routine drugs to control nausea and vomiting caused by chemotherapy, the control group will receive two placebo capsules daily for one week. Each placebo capsule contains 150 mg of starch. These capsules are made in the pharmacology department of medicinal plants of Yasouj University of Medical Sciences. Nausea and vomiting. Timepoint: The number of nausea and vomiting episodes is recorded within 24 hours. Method of measurement: Registration in Common Toxicity Criteria (CTC). Quality of Life. Timepoint: One week after chemotherapy. Method of measurement: Pediatric Quality of Life inventory4.0 Acute. Yasouj University of Medical Sciences Approved 2022-05-31 Ethics Committee of Yasuj University of Medical Sciences shahid Jalil Street, Educational Pardis, Yasuj. Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)