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IRCT20220912055947N1 IRCT 2022-12-11 Bam University of Medical Sciences the effect of cumin and Kermani sumac herbal product in preventing nausea and vomiting Investigating the effect of sumac and cumin plant products in preventing nausea and vomiting after surgery 2022-09-23 anticipated 120 Complete https://irct.ir/trial/65865 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: All eligible patients are randomly assigned to treatment and control groups using a random number table using random permutation blocks, Blinding description: In order to give medicine to patients in the hospital, a reliable person who has sufficient knowledge to do this work is selected and by using random permutation block method, it is determined what medicine each person will receive.The researcher and the patient do not know what medicine is received.Drug and placebo are similar in term of shape and appearance. 3 Nausea and vomiting after surgery. Intervention 1: Intervention group: Method First, the alcoholic extract of the formulation is prepared, then the total phenolic content is measured using Fulin-Sio-Calto reagent. 0.5 ml of the extract is added to 2.5 ml of Folin Sio Calto 0.2 normal reagent, after 5 minutes 2 ml of 75 g/l sodium carbonate solution is added to it. After 2 hours, absorbance of the mixture at 760 nm wavelength is read by a spectrophotometer against a blank. To determine the amount of the sample, tannic acid standard is used to draw the calibration chart.This test is performed three times. In order to determine the amount of raw material ash, which is used to check the percentage of raw material impurities, first, 5 grams of the weighed sample is poured into a porcelain crucible that has already been cleaned, dried and weighed. then the plants are placed in an electric furnace and heated for 6 hours at a temperature of 400-500 degrees Celsius, and then the samples are placed in a desiccator and weighed after cooling. The percentage of total ash is calculated by dividing the difference of the final weight of the plant from the initial plant by the weight of the sampled material and the result is reported as a percentage.In order to determine the moisture level of the plant, 5 grams of the medicinal plant sample is placed in a clean porcelain crucible at a temperature of 100 degrees Celsius for 24 hours, and the weight loss of the sample is presented as a percentage. In order to perform microbial tests of the formulation sample, first 5 grams of phosphate buffer solution with pH = 7.2 is added to the sample, then the plate-cont method according to the USP pharmacopoeia is used. In this way, one milliliter of the prepared sample is poured into a petri dish and 15 to 20 milliliters of Soybean Casein Digest Agar or Sabouraud Dextrose Agar are added to it.The plates are kept at a temperature of 30-35 degrees Celsius for one week, then the number of colonies created is counted. People in the case group receive 2 four-gram sachets containing sumac and cumin. Sachets containing sumac and cumin products are taken every 12 hours, 24 hours before surgery, along with a glass of cool water. Intervention 2: Control group:People in the control group receive 2 sachets containing corn starch and caramel as a placebo in the same way. The way of consuming the diet is that the patients take the sachets containing placebo together with a glass of cold water, 24 hours before surgery. They eat every 12 hours. 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 further information
public mohadeseh nasehi
Bam Moalem Blvd. 12 Moalem Alley
bam Iran (Islamic Republic of) 7661745937 +98 34 4434 0768 mohinasehi@yahoo.com Bam University of Medical Sciences scientific mohadeseh nasehi
Bam Moalem Blvd. 12 Moalem Alley
bam Iran (Islamic Republic of) 7661745937 +98 34 4434 0768 mohinasehi@yahoo.com Bam University of Medical Sciences Iran (Islamic Republic of) 1) Age between 18 and 65 years 2) Absence of underlying disease including diabetes, heart, kidney, liver, and Malori Weiss disease 3) Absence of stomach and intestinal ulcers 4) Declaration of consent to participate in the research and signing the informed consent form 5) Absence of obstruction Gut 6) Absence of sensitivity to sumac and cumin 18 years 65 years Both The patient's unwillingness to continue the treatment Failure to respond to herbal medicine Occurrence of any symptoms of allergy to the herbal product during treatment Observing any complications during treatment Parkinson's disease Y84 Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Treatment - Drugs Placebo Intervention group: Method First, the alcoholic extract of the formulation is prepared, then the total phenolic content is measured using Fulin-Sio-Calto reagent. 0.5 ml of the extract is added to 2.5 ml of Folin Sio Calto 0.2 normal reagent, after 5 minutes 2 ml of 75 g/l sodium carbonate solution is added to it. After 2 hours, absorbance of the mixture at 760 nm wavelength is read by a spectrophotometer against a blank. To determine the amount of the sample, tannic acid standard is used to draw the calibration chart.This test is performed three times. In order to determine the amount of raw material ash, which is used to check the percentage of raw material impurities, first, 5 grams of the weighed sample is poured into a porcelain crucible that has already been cleaned, dried and weighed. then the plants are placed in an electric furnace and heated for 6 hours at a temperature of 400-500 degrees Celsius, and then the samples are placed in a desiccator and weighed after cooling. The percentage of total ash is calculated by dividing the difference of the final weight of the plant from the initial plant by the weight of the sampled material and the result is reported as a percentage.In order to determine the moisture level of the plant, 5 grams of the medicinal plant sample is placed in a clean porcelain crucible at a temperature of 100 degrees Celsius for 24 hours, and the weight loss of the sample is presented as a percentage. In order to perform microbial tests of the formulation sample, first 5 grams of phosphate buffer solution with pH = 7.2 is added to the sample, then the plate-cont method according to the USP pharmacopoeia is used. In this way, one milliliter of the prepared sample is poured into a petri dish and 15 to 20 milliliters of Soybean Casein Digest Agar or Sabouraud Dextrose Agar are added to it.The plates are kept at a temperature of 30-35 degrees Celsius for one week, then the number of colonies created is counted. People in the case group receive 2 four-gram sachets containing sumac and cumin. Sachets containing sumac and cumin products are taken every 12 hours, 24 hours before surgery, along with a glass of cool water. Control group:People in the control group receive 2 sachets containing corn starch and caramel as a placebo in the same way. The way of consuming the diet is that the patients take the sachets containing placebo together with a glass of cold water, 24 hours before surgery. They eat every 12 hours. Severe nausea. Timepoint: At zero hours, 4 hours after surgery, 8 hours after surgery, 16 hours after surgery, 24 hours after surgery, the severity of nausea and frequency of vomiting during the 24-hour period are evaluated. Method of measurement: VAS criterion. Number of times vomiting. Timepoint: At zero hours, 4 hours after surgery, 8 hours after surgery, 16 hours after surgery, 24 hours after surgery, the severity of nausea and frequency of vomiting during the 24-hour period are evaluated. Method of measurement: VAS criterion. Nember of times vomiting. Timepoint: At the beginning of the study, 4, 8, 16, 24 hours after surgery. Method of measurement: VAS criterion. Bam University of Medical Sciences Approved 2022-05-18 Ethics Committee of Bam University of Medical Sciences Pastor Hospital, Kilometer 5 Bam Baravat Road , Bam,Kerman Bam Kerman Iran (Islamic Republic of)