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IRCT20230807059069N1 IRCT 2023-10-24 Mazandaran University of Medical Sciences The effect of Galenos Barij Syrup on nausea and vomiting caused by chemotherapy with strong emetic ability compared to standard treatment. Comparison of the effectiveness of Galenos Barij Syrup on preventing nausea and vomiting in patients referred to outpatient chemotherapy receiving the regime with high emetic chemotherapy (HEC) compared to the standard regime 2023-09-23 anticipated 56 Complete https://irct.ir/trial/71862 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random allocation will be done by block method (Randomization Block) with a block size of four and using Sealed Envelope online software at the address https://www.sealedenvelope.com at an individual level and by an epidemiologist researcher who is a member of the research team. In this site, which is an online software for creating random allocation, the create list option is selected through the randomization menu, and then the required parameters such as groups A and B, the number of blocks, which is 4, and the total number of samples will be entered. And finally the random allocation list will be created. A sealed non-transparent envelope will be used for concealment. Researchers enroll eligible participants after the baseline assessment, then remove and open each envelope in the order that corresponds to the participant's initial assessment order, and assign the eligible participant to either the intervention group or the control group. 3 Chemotherapy. Intervention 1: Intervention group: In our current study, we used 5-10 cc barrage syrup based on person weight. Barrage syrup is containing fruit (Cydonia oblonga), ginger (Zingiberofficinale), vinegar and honey as an adjunctive treatment to the standard treatment containing a 5-HT3R inhibitor (Granicitron (Kytril brand)), NK1 receptor antagonist ( We will use aperpitant (amand brand name) and dexamethasone.The anti-nausea effect of this product is on the one hand due to the presence of "Bah" fruit extract and on the other hand due to the presence of ginger. It becomes natural. Also, consuming "beh" after meals helps to eliminate indigestion and improve the digestive condition.Natural honey has antimicrobial and antibacterial properties and other enzymes that produce a small amount of hydrogen peroxide. Hydrogen peroxide, in turn, relieves you of indigestion. Natural honey contains the enzymes invertase, catalase, peroxidase, glucose oxidase, phosphatase and enolase acid, which help in proper digestion. It also contains potassium, which relieves nausea and inflammation of the lining of the esophagus and helps the stomach to neutralize acids. Honey is anti-nausea, and regular consumption of honey affects the muscles of the stomach and helps with proper digestion. . Also, natural honey stabilizes the content of hydrochloric acid in the body.Being rich in some vitamins, vinegar is very effective in the health of the digestive system and its elimination of toxins. It also has a significant effect in the treatment of some diseases and disorders of the digestive system, such as better digestion of food and reduction of nausea. Intervention 2: Control group: According to the clinical guidelines for the prevention of CINV in people undergoing chemotherapy with a high risk of emesis (HEC), a combination of 5-HT3 receptor antagonist (Granicitron 3 mg), NK-1 receptor antagonist (Aprepitant 125 mg daily) and dexamethasone 8 mg will be used as the standard before chemotherapy and a combination of aprepitant and dexamethasone will be given on days 2 and 3 and dexamethasone on day 4. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main result or the like, can be shared. When: Since 2025 To whom: It will be available only to researchers working in academic and scientific institutions Conditions: There are no other conditions for the use of data or documentation. No analysis is allowed on the delivered data. Where to obtain: MOHAMMAD MEHDI VAZIRI drmmvaziri@gmail.com How to obtain: After communicating through the above email, the desired request will be submitted Comments:
public Mohammad Mehdi Vaziri
Razi Ave.
Sari Iran (Islamic Republic of) 48816633131 +98 11 3336 4044 drmmvaziri@gmail.com Mazandaran University of Medical Sciences scientific Mohammad Mehdi Vaziri
Razi
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 4044 drmmvaziri@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) People over the age of 18 Patients under high emetogenic chemotherapy regimens (HEC) referring to outpatient chemotherapy at Imam Khomeini Hospital and Baghban Complex 18 years no limit Both Allergy to ginger Ginger consumption within a week before the start of the intervention Users of warfarin, heparin and aspirin drugs History of neurological diseases, history of seizures and epilepsy, history of blood disorders Patients with bowel obstruction or brain or bowel metastasis Lack of consent to participate in the study Z51.1 Encounter for Antineoplastic Chemotherapy and Immunotherapy Treatment - Drugs Treatment - Drugs Intervention group: In our current study, we used 5-10 cc barrage syrup based on person weight. Barrage syrup is containing fruit (Cydonia oblonga), ginger (Zingiberofficinale), vinegar and honey as an adjunctive treatment to the standard treatment containing a 5-HT3R inhibitor (Granicitron (Kytril brand)), NK1 receptor antagonist ( We will use aperpitant (amand brand name) and dexamethasone.The anti-nausea effect of this product is on the one hand due to the presence of "Bah" fruit extract and on the other hand due to the presence of ginger. It becomes natural. Also, consuming "beh" after meals helps to eliminate indigestion and improve the digestive condition.Natural honey has antimicrobial and antibacterial properties and other enzymes that produce a small amount of hydrogen peroxide. Hydrogen peroxide, in turn, relieves you of indigestion. Natural honey contains the enzymes invertase, catalase, peroxidase, glucose oxidase, phosphatase and enolase acid, which help in proper digestion. It also contains potassium, which relieves nausea and inflammation of the lining of the esophagus and helps the stomach to neutralize acids. Honey is anti-nausea, and regular consumption of honey affects the muscles of the stomach and helps with proper digestion. . Also, natural honey stabilizes the content of hydrochloric acid in the body.Being rich in some vitamins, vinegar is very effective in the health of the digestive system and its elimination of toxins. It also has a significant effect in the treatment of some diseases and disorders of the digestive system, such as better digestion of food and reduction of nausea. Control group: According to the clinical guidelines for the prevention of CINV in people undergoing chemotherapy with a high risk of emesis (HEC), a combination of 5-HT3 receptor antagonist (Granicitron 3 mg), NK-1 receptor antagonist (Aprepitant 125 mg daily) and dexamethasone 8 mg will be used as the standard before chemotherapy and a combination of aprepitant and dexamethasone will be given on days 2 and 3 and dexamethasone on day 4. The Rhodes Index questionnaire will evaluate the main outcome of the study. This tool (Nausea and Vomiting Index) is designed as a 5-point Likert scale (score 0-4). The final score range will vary between 0-32. In order to interpret the scores obtained from the questionnaire, the average scores related to nausea and vomiting in each group were calculated. The Rhodes questionnaire will be completed daily.All patients were provided with a daily side effect checklist at the first visit to the outpatient chemotherapy clinic. Using the checklist, patients will record daily their nausea with a numerical rating scale (NRS) (0-10) and the number of times or episodes of vomiting up to 7 days after chemotherapy. The physician implementing the plan will record the amount of control of nausea and vomiting in the medical record after confirming the data or hearing the results of the patients at the next visit. Complete protection from nausea (NRS <1) and vomiting (no episodes) during the acute (within 24 hours after chemotherapy) and delayed (within 2 to 7 days after chemotherapy) episodes in patients receiving the first cycle of chemotherapy or will be evaluated in general cycles of chemotherapy. Timepoint: Patients will record daily nausea (0-10) and the number of times or episodes of vomiting up to 7 days after chemotherapy. Method of measurement: Rhodes Index Questionnaire. Mazandaran University of Medical Sciences Approved 2022-07-10 Imam (RA) Sari Educational and Medical Hospital - Mazandaran University of Medical Sciences (Researc Imam Khomeini Hospital, Razi St. Sari Mazandaran Iran (Islamic Republic of)