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IRCT20210109049973N1 IRCT 2023-11-25 Iran University of Medical Sciences The effect of chamomile on the incidence and severity of nausea and vomiting after middle ear surgery The effect of chamomile on the incidence and severity of nausea and vomiting on patients undergoing middle ear surgery 2023-11-21 anticipated 110 Complete https://irct.ir/trial/73624 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The samples are selected as available and will be distributed in two intervention and control groups based on random allocation by tossing a coin (on the back and on the coin). In this way, the face of the coin will be related to the intervention group and the back of the coin will be related to the control group. After entering the patients and checking the entry criteria, a coin will be tossed by an unknown person to assign the groups. If the coin comes up, the patient will enter the intervention group, and if the coin comes up, the patient will be in the control group, Blinding description: For blindness, according to the triple-blind approach, the capsules made with the same shape by the pharmacist are placed in two envelopes. the person doing sampling, the patient receiving medication, and finally the statistical consultant analyzing data do not know about the allocation of samples in control and intervention groups. the intervention group will be identified by the letter A and the control group by the letter B to prevent bias in collecting and recording the results of the study and to generalize the results. N/A Post anesthesia nausea and vomiting. Intervention 1: Intervention group: patients who receive 500 mg chamomile capsules 1 hour before surgery. Intervention 2: Control group: patients who receive placebo (corn starch) 1 hour before surgery. Yes - There is a plan to make this available What will be shared: All data cannot be shared When: None To whom: None Conditions: Only in situations where a meta-analysis is to be performed Where to obtain: Parisa Moradi Majd moradimajd.p@gmail.com How to obtain: From Email Comments:
public Parisa Moradi Majd
Iran university of medical sciences,next to milad tower, hemmat highway, tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4772 moradimajd.p@gmail.com Iran University of Medical Sciences scientific Parisa moradi majd
Iran university of medical sciences,next to milad tower, hemmat highway, tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4772 moradimajd.p@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age 18_65 years old ASA I and ASA II Not taking antiemetic drugs 24 hours before surgery Platlate count above 100000 Weight less than 90 kg No liver disease (hepatitis, coagulation disorder), renal disease (kidney stone, renal failure), and gastrointestinal (stomach ulcer, duodenal ulcer) No history of motion sickness No cancer Being NPo No history of hypertension No history of epilepsy No pregnancy No smoking No allergies to chamomile 18 years 65 years Both Prevention N/A Intervention group: patients who receive 500 mg chamomile capsules 1 hour before surgery Control group: patients who receive placebo (corn starch) 1 hour before surgery Rate of nausea and vomiting after middle ear surgery. Timepoint: Immediately after recovery from anesthesia, 1, 2, 4 and 6 hours after recovey from anesthesia. Method of measurement: Rhodes index. Vital sign. Timepoint: Immediately, 1,2,4,6 hours after recovery from anesthesia. Method of measurement: Observation, termometer and blood pressure monitoring. Iran University of Medical Sciences Approved 2021-07-18 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)