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IRCT20171203037733N4 IRCT 2021-12-15 Arak University of Medical Sciences Effect of pippermint on nausea in pediatrics with leukemia undergoing chemotherapy Effect of Peppermint (Mentha piperita) on Nausea, Vomiting and Anorexia in pediatrics with leukemia Undergoing Chemotherapy: A Randomized Controlled Trial 2021-12-21 anticipated 68 Complete https://irct.ir/trial/54426 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are available from among children with acute myeloid leukemia and lymphocytosis undergoing chemotherapy. The samples are then assigned to two random groups as random quadruple blocks A, A, B, and B.It should be noted that the Rand function in Excel software will be used for randomization. The statistician and the sample collector are not aware of how the samples are blinded, Blinding description: The statistician will do the randomization, one of the colleagues will do the sampling plan, and the treating physician will assign the patients to the groups. The statistician and the sample collector are not aware of how the samples are blinded. 3 Nausea, vomiting and Anorexia. Intervention 1: Intervention group: The samples are assigned to two random groups as quadruple random blocks A, A, B, and B. First, written and informed consent was obtained from the patients. Then, with the help of VAS visual scale, the amount of nausea and anorexia and with the help of frequency table, the number of vomiting cases in the day before chemotherapy in the intervention and control groups are examined. In the intervention group, in addition to routine anti-nausea treatments, 12 hours before chemotherapy and up to 48 hours after, 1 drop in weight (1 Drop per kilogram) every 8 hours, peppermint extract (Super Mate drops) (Barij Essence Pharmaceutical Company) with 20 cc Urban tap water is given to patients (measurement of nausea, vomiting and anorexia half an hour before chemotherapy, immediately, 24 and 48 hours after chemotherapy) .All medications taken are recorded by the sample collector. Intervention 2: Control group: In the control group, they receive only routine anti-nausea drugs and their nausea, vomiting and anorexia are measured by VAS scale half an hour before chemotherapy, immediately, 24 and 48 hours after re-chemotherapy. 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 final decision to publish yet.
public Mehran Akbari
Postal Code: 38817-43364, Azadi St., Khomein School of Medical Sciences, Khomein, Iran
khomein Iran (Islamic Republic of) 38817-43364 +98 86 4622 1534 mehranakbari1373@yahoo.com Khomein University of Medical Sciences scientific Mehran Ahbari
Azadi St., Khomein School of Medical Sciences, Khomein, Iran
Khomein Iran (Islamic Republic of) 38817-43364 +98 86 4622 1534 mehranakbari1373@yahoo.com Khomein University of Medical Sciences Iran (Islamic Republic of) Written conset to participate in the study Definitive diagnosis of myeloid leukemia and acute lymphocytic (ALL and AML) by a pediatric hematologist and oncologist (other than None M3ALL ) Receiving chemotherapy courses History of receiving at least one course of chemotherapy Experience of nausea following previous chemotherapy sessions No concomitant radiotherapy with chemotherapy Age 3 to 18 years 3 years 18 years Both Using medications or other treatments to reduce nausea other than the usual prescribed anti-nausea and vomiting medications (especially herbal remedies) Nausea and vomiting resistant to treatment Unwillingness to participating in the study sensitivity to mint other nausea problems such as hypertention , liver failure , kidney and digestive problems R11 Nausea and vomiting Treatment - Drugs Other Intervention group: The samples are assigned to two random groups as quadruple random blocks A, A, B, and B. First, written and informed consent was obtained from the patients. Then, with the help of VAS visual scale, the amount of nausea and anorexia and with the help of frequency table, the number of vomiting cases in the day before chemotherapy in the intervention and control groups are examined. In the intervention group, in addition to routine anti-nausea treatments, 12 hours before chemotherapy and up to 48 hours after, 1 drop in weight (1 Drop per kilogram) every 8 hours, peppermint extract (Super Mate drops) (Barij Essence Pharmaceutical Company) with 20 cc Urban tap water is given to patients (measurement of nausea, vomiting and anorexia half an hour before chemotherapy, immediately, 24 and 48 hours after chemotherapy) .All medications taken are recorded by the sample collector. Control group: In the control group, they receive only routine anti-nausea drugs and their nausea, vomiting and anorexia are measured by VAS scale half an hour before chemotherapy, immediately, 24 and 48 hours after re-chemotherapy. Nausea. Timepoint: Before, immediately, 24 hours, 48 hours after chemotherapy. Method of measurement: VAS questionnaire and measurement table and Face scale. Vomiting. Timepoint: Before, immediately, 24 hours, 48 hours after chemotherapy. Method of measurement: VAS questionnaire and measurement table and Face scale. Anorexia. Timepoint: Before, immediately, 24 hours, 48 hours after chemotherapy. Method of measurement: VAS questionnaire and measurement table and Face scale. Arak University of Medical Sciences Approved 2021-11-08 Ethics committee of Arak University of Medical Sciences Arak Univerity of Medical Sciences, Payambar aazam, University Complex, Basij SQ, Sardasht region Arak Markazi Iran (Islamic Republic of)