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IRCT20220317054317N1 IRCT 2022-04-04 Ghoum University of Medical Sciences The effect of "Maoljobon ( whey)" on Cancer patients with chemotherapy induced "hand and foot syndrome" EMCHFS The effect of "Maoljobon ( whey)" on Cancer patients with chemotherapy_ induced "hand and foot syndrome" and their quality of life 2022-05-05 anticipated 60 Complete https://irct.ir/trial/62565 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: In the first step, the groups are written as groups A and B. A lottery is then drawn between the two groups to determine which letter is in the intervention group and which is in the control group. In the second step, 60 numbers, from one to 60, are written on paper and completely closed so that they are not visible and are thrown into a container. Then, in the third step, a person will announce that the patients will choose the intervention or control group, then pick up a number from the container and read it and take notes in the group that announced it. This is done 30 times without substitution until all the people in the announced group are identified, then the remaining 30 numbers are assigned to the second group. Finally, when patients come to the clinic, each patient has a number from inside a container that contains 60 numbers from one to 60 and is written on paper and is not visible, and gives it to the therapist, then the therapist opens the number paper and Looks at the list of groups. The selected number belongs to each group. The patient is placed in that group and this is done up to 60 times to complete the groups, Blinding description: During the study and sampling, the therapist, researcher and patients will not know the type of group (control or intervention) and try to invite patients to visit at a distance so as not to meet each other and not be informed about the content of the treatment. The distribution of medicine according to the group list will be done by one of the staff of the center who is not involved in the examination and collection of information. After collecting the data, the analyzers will not know the patient group. 3 Chemotherapy-induced hand and foot syndrome. The brewery is the whey that is obtained as a by-product of cheese production, after the separation of milk casein, and contains lactose and a variety of proteins, minerals, vitamins, and fats. Depending on the type of milk and methods of this process, various products are created. In this project, among the methods of coagulation of milk in traditional medicine by vinegar, peppermint or shoe eggs, the type of peppermint has been selected. Freshly boiled milk will be cut through powdered sugar and a little vinegar. After the milk is completely cut, the container is removed from the fire. The contents of the container, which is still slightly warm, are poured into a fine-textured canvas cloth and the water is collected in a container. After collecting the liquid, it is turned into powder in the freezer and packaged Intervention group: People in the intervention group consumed 15 grams of malt powder twice a day, morning, morning, and evening, which should be dissolved in 100 ccs of lukewarm boiled water, and sip, and consumed until one hour later. Do not eat anything. The use of malt water will be for 6 weeks and 2 days. At the same time, for both control and intervention groups, 20% glycerin ointment; Use topically.After preparing the powder in one of the reputable laboratories, it is examined for fungi and microbes, and after making sure that no microbial and fungal counts have grown in the powder product, it will enter the clinical phase.. Yes - There is a plan to make this available What will be shared: Data will be sent on request by researchers. When: After printing the study results To whom: researchers Conditions: For systematic review studies or meta-analysis Where to obtain: Dr. Majid Asghari How to obtain: Correspondence by email with the project manager Comments:
public Akram Ashoori
15 Khordad Boulevard, next to Alley 44, Qom School of Persian Medicine
Qom Iran (Islamic Republic of) 3714848350 +98 25 3776 4073 aashori@muq.ac.ir Ghoum University of Medical Sciences scientific Majid Asghari
15 Khordad Boulevard, next to Alley 44, Qom School of Traditional Medicine
Qom Iran (Islamic Republic of) 3714848350 +98 25 3776 4073 Asghari.rall@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) All patients over 18 years of age with hand syndrome and reason for chemotherapy, from Capecitabine, who are willing to participate in the study. 18 years no limit Both Patients with other skin lesions - Infection - Inflammatory bowel disease - History of severe milk allergy Rehabilitation The brewery is the whey that is obtained as a by-product of cheese production, after the separation of milk casein, and contains lactose and a variety of proteins, minerals, vitamins, and fats. Depending on the type of milk and methods of this process, various products are created. In this project, among the methods of coagulation of milk in traditional medicine by vinegar, peppermint or shoe eggs, the type of peppermint has been selected. Freshly boiled milk will be cut through powdered sugar and a little vinegar. After the milk is completely cut, the container is removed from the fire. The contents of the container, which is still slightly warm, are poured into a fine-textured canvas cloth and the water is collected in a container. After collecting the liquid, it is turned into powder in the freezer and packaged Intervention group: People in the intervention group consumed 15 grams of malt powder twice a day, morning, morning, and evening, which should be dissolved in 100 ccs of lukewarm boiled water, and sip, and consumed until one hour later. Do not eat anything. The use of malt water will be for 6 weeks and 2 days. At the same time, for both control and intervention groups, 20% glycerin ointment; Use topically.After preparing the powder in one of the reputable laboratories, it is examined for fungi and microbes, and after making sure that no microbial and fungal counts have grown in the powder product, it will enter the clinical phase. The amount of pain in the lesions. Timepoint: Before the intervention, one day and one week after the intervention period. Method of measurement: visual analog scale. Degree of waste. Timepoint: Before the intervention, one day and one week after the intervention period. Method of measurement: Common Terminology Criteria for Adverse Event. The amount of burning and itching and numbness of the lesions. Timepoint: Before the intervention, one day and one week after the intervention period. Method of measurement: Likert Questionnaire. Scaling rate and redness of the lesions. Timepoint: Before the intervention, one day and one week after the intervention period. Method of measurement: Dermatologist photography and opinion. Overall quality of life. Timepoint: before the intervention and one day and one week after the intervention period. Method of measurement: (Quality of Life)questionnaire. Quality of life of a skin patient. Timepoint: before the intervention and one day and one week after the intervention period. Method of measurement: Dermatology Life Quality Index questionnaire. Ghoum University of Medical Sciences Approved 2022-03-06 Ethics committee of ًQom University of Medical Sciences Safashahr St., University Jihad Alley, Shahid Lotfi Niasar (Alley No. 4), No. 83 qom Ghoum Iran (Islamic Republic of)