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IRCT20220315054291N1 IRCT 2022-08-10 Mazandaran University of Medical Sciences Effect of blackberry syrup on tonsil hypertrophy Investigating the effect of blackberry syrup on reducing hypertrophy of tonsils and its clinical symptoms in patients aged 5 to 15 years 2022-07-23 anticipated 72 Complete https://irct.ir/trial/62647 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, random assignment of patients to experimental and control groups will be done using the quadruple random blocks method. We know that the number of possible blocks of four of the two letters A and B is equal to 6; As follows: (AABB-ABAB-ABBA-BAAB-BABA-BBAA) If we denote them by the numbers 1 to 6, to randomly assign them using blocks of 4, first by throwing 18 regular hexagons, a random sequence of numbers 1 to 6 into 18 blocks of 4 from the sub-generated blocks Will: In the desired sequence, there will be 36 letters from each letter A and B. According to the above blocks, 72 envelopes will be prepared and in each envelope, the letter A or B will be placed and will be numbered from 1 to 72. The person delivering the envelopes to the patients does not know what is inside. The production of a random sequence is done by a statistics and methodology consultant who does not have access to patients and only he knows what is in each issue. Patients who received the letter A will be in the intervention group and patients who received the letter B will be in the control group, Blinding description: Patients with tonsillar hypertrophy are randomly divided into intervention and placebo groups according to the inclusion criteria. After random sampling and determining whether the patient belongs to the intervention or control group, it is justified by the clinical caregiver and The required training is provided and the package containing the guide and medication brochure will be delivered to patients. In addition to oral explanations about how to study, how to use the drug, the amount and time of use and frequency and duration of treatment are explained. Intervention and control groups will be performed using the quadruple random blocks method. According to the above blocks, 72 envelopes will be prepared and in each envelope, the letter A or B will be placed and will be numbered from 1 to 72. The person delivering the envelopes to the patients does not know what is inside. The production of a random sequence is done only by a "statistics and methodology consultant" who does not have access to patients and only he knows what is in each issue. Patients who received the letter A in the intervention group and patients who received the letter B. All patients will not be aware of the type of drug in the package, including one of the placebo or the main drug under study. 3 Tonsil hypertrophy. Intervention 1: Intervention group: patients slowly eat blackberry syrup for 4 weeks by taking one tablespoon of 5 cc in patients three times a day including morning, noon and night (about 10 seconds) should be kept in the mouth and not swallowed quickly to provide more contact between the syrup and the pharynx and tonsils. Blackberries and 30% honey are prepared by a reputable pharmaceutical factory under sterile conditions and during the pharmaceutical and pharmaceutical processing stages in 120 cc jars. Honey is used as a reformer of blackberries in this product. Blackberries are rich in polyphenols. Among them is anthocyanin, which is a strong antioxidant. Anthocyanin has strong antioxidant, anti-proliferative, and anti-inflammatory properties that can be used in the treatment or prevention of inflammatory diseases and prevent the inappropriate growth and proliferation of cells. Patients are treated by the assistant of traditional medicine. justified and provide the necessary training and recommendations Parents of the patients are explained and trained on how to conduct the study, how to use the drug under study. In addition, during one month, they should observe the necessary precautions in case of tonsillitis, including avoiding drinking very cold liquids, ice water, consuming vinegar, and pickles. Outside the house and washing hands and face after entering the house will be emphasized. In addition to providing verbal explanations, a brochure containing necessary recommendations has been prepared and will be delivered to the patients along with the medicine. Intervention 2: Control group: For 4 weeks, patients slowly eat the placebo oral syrup by taking one tablespoon of 5 cc, three times a day including morning, noon and night after meals, and it will be recommended to take the syrup a little longer (about 10 seconds) should be kept in the mouth and not swallowed quickly. Placebo oral syrup is a combination of water, glucose and permitted food coloring, which is prepared by a reputable pharmaceutical factory under sterile conditions and during the pharmaceutical and pharmaceutical processing stages in 120 cc bottles.The patients are justified by the traditional medicine assistant and the necessary training and recommendations are provided. The parents of the patients are taught that during one month, the necessary precautions for tonsillitis, including avoiding drinking very cold liquids, ice water, and consuming vinegar Also, it will be emphasized on the necessity of following health protocols in order to prevent the occurrence of infections such as colds, including wearing a mask outside the house and washing hands and face after entering the house. It includes the necessary recommendations that will be delivered to the patients along with the medicine Headed. 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 more information
public Yousefi Seyedeh Sedigheh
Khazar Square, Khazar Boulevard, Center for Traditional and Complementary Medicine, Mazandaran University
Sari Iran (Islamic Republic of) 4816895475 +98 11 3324 4893 s.yousefi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Yousefi Seyedeh Sedigheh
Khazar Square, Khazar Boulevard, Center for Traditional and Complementary Medicine, Mazandaran University
Sari Iran (Islamic Republic of) 4816895475 +98 11 3324 4893 s.yousefi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with chronic tonsillar hypertrophy Being in the age range of 5 to 15 years Willingness to participate in this research Tendency to consume traditional medicine medicinal products 5 years 15 years Both Having Acute tonsillitis Having tonsillar abscess Having unstable clinical conditions Take systemic corticosteroids 4 weeks before the intervention Take antibiotics 4 weeks before the intervention Sensitivity to blackberry Sensitivity to honey Demonstrate signs of incompatibility with the consumption of blackberry syrup Inability to communicate Patient's unwillingness to continue cooperating in the study J35.1 Hypertrophy of tonsils Treatment - Drugs Placebo Intervention group: patients slowly eat blackberry syrup for 4 weeks by taking one tablespoon of 5 cc in patients three times a day including morning, noon and night (about 10 seconds) should be kept in the mouth and not swallowed quickly to provide more contact between the syrup and the pharynx and tonsils. Blackberries and 30% honey are prepared by a reputable pharmaceutical factory under sterile conditions and during the pharmaceutical and pharmaceutical processing stages in 120 cc jars. Honey is used as a reformer of blackberries in this product. Blackberries are rich in polyphenols. Among them is anthocyanin, which is a strong antioxidant. Anthocyanin has strong antioxidant, anti-proliferative, and anti-inflammatory properties that can be used in the treatment or prevention of inflammatory diseases and prevent the inappropriate growth and proliferation of cells. Patients are treated by the assistant of traditional medicine. justified and provide the necessary training and recommendations Parents of the patients are explained and trained on how to conduct the study, how to use the drug under study. In addition, during one month, they should observe the necessary precautions in case of tonsillitis, including avoiding drinking very cold liquids, ice water, consuming vinegar, and pickles. Outside the house and washing hands and face after entering the house will be emphasized. In addition to providing verbal explanations, a brochure containing necessary recommendations has been prepared and will be delivered to the patients along with the medicine. Control group: For 4 weeks, patients slowly eat the placebo oral syrup by taking one tablespoon of 5 cc, three times a day including morning, noon and night after meals, and it will be recommended to take the syrup a little longer (about 10 seconds) should be kept in the mouth and not swallowed quickly. Placebo oral syrup is a combination of water, glucose and permitted food coloring, which is prepared by a reputable pharmaceutical factory under sterile conditions and during the pharmaceutical and pharmaceutical processing stages in 120 cc bottles.The patients are justified by the traditional medicine assistant and the necessary training and recommendations are provided. The parents of the patients are taught that during one month, the necessary precautions for tonsillitis, including avoiding drinking very cold liquids, ice water, and consuming vinegar Also, it will be emphasized on the necessity of following health protocols in order to prevent the occurrence of infections such as colds, including wearing a mask outside the house and washing hands and face after entering the house. It includes the necessary recommendations that will be delivered to the patients along with the medicine Headed. The size of the tonsils according to the Brodsky scale. Timepoint: Beginning of the study (before the intervention). Method of measurement: Tonsil size classification with Brodsky scale. The size of the tonsils according to the Brodsky scale. Timepoint: 4 weeks after intervention (after taking blackberry syrup or placebo). Method of measurement: Tonsil size classification with Brodsky scale. Mazandaran University of Medical Sciences Approved 2022-03-19 Ethics committee of Mazandaran University of Medical Sciences Khazar Boulevard, next to Touba Clinic, Faculty of Traditional Medicine, second floor Sari Mazandaran Iran (Islamic Republic of)