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IRCT20220706055388N2 IRCT 2023-06-27 Khoram-Abad University of Medical Sciences Comparison of the effects of Bathing with Cichorium intybus and Fumaria Officinalis on Icter Comparing the Effects of Bathing with Cichorium intybus and Fumaria officinalis Water Extracts on the Icter Neonates 2023-06-26 anticipated 93 Complete https://irct.ir/trial/70755 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Allocation of samples in groups will be done using the random block method. To equalize the distribution of the confounding variables of gender, birth weight, and gestational age, first classes based on these variables are described as girl/boy, weight less than 2500 grams/weight more than 2500 grams, and gestational age less than 37 weeks/37 weeks and above, and then they are balanced in the studied groups by the random block method. After that, they are divided into three groups (one control group and two intervention groups) in a simple random manner using a table of random numbers. 2-3 jaundice. Intervention 1: First Intervention Group: This group will receive both phototherapy and bathing with Cichorium intybus extract. These Neonates were treated with sterile cotton before starting phototherapy and then for 2 days, once a day, after feeding at noon when phototherapy is stopped for health care and other cases, with 250 ml of Cichorium intybus extract. They bathe for 5 to 7 minutes. The room temperature is set at 24-28 degrees Celsius. Cichorium intybus extract is also heated to a temperature of 37.5 degrees Celsius. (Cichorium intybus refers to the aqueous extract of the leaves of this plant. The preparation of the aqueous extract of this medicinal plant is done daily in the laboratory in accordance with the principles of extraction by the pharmaceutical chemist under the supervision of the project's pharmacist. 50 grams of ground Cichorium intybus in 250 cc of water The distillate is soaked at laboratory temperature for 72 hours away from sunlight. Then it is smoothed with Whatman filter paper and prepared for intervention in disposable bottles with a capacity of half a liter. The extracts are stored in the treatment room of the hospital wards at temperature properly maintained and used on a daily basis). Intervention 2: Second Intervention Group: This group will receive both phototherapy and bathing with Fumaria officinalis extract. These Neonates were first hospitalized using sterile cotton before starting phototherapy and then for 2 days, once a day, after feeding at noon, when phototherapy is stopped for health care and other cases, with 250 ml of Fumaria officinalis extract. They bathe for 5 to 7 minutes. The room temperature is set at 24-28 degrees Celsius. Fumaria officinalis refers to the aqueous extract of the leaves of this plant. The preparation of the aqueous extract of this medicinal plant is done daily in the laboratory by following the principles of extraction by a pharmaceutical chemist under the supervision of a project pharmacist. It is dried at room temperature and away from direct sunlight and is ground into powder using a mill. The powder obtained from Fumaria officinalis leaves is mixed with distilled water in a ratio of 1 to 9 (50 grams of powder in 450 cc of distilled water) and boiled for 10 to 15 minutes. Then the extract is filtered using Whatman paper and stored in colored glass until consumption. Intervention 3: Control Group: This group receives only phototherapy (single, double and intense). Being single, double and severe also depends on the Neonate's bilirubin level. Thus, the high bilirubin level receives a severe type. Before starting phototherapy, all Neonates are examined for Coombs, glucose-6-phosphate dehydrogenase, total and direct bilirubin levels, and mother's and Neonate's Rh blood group. 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 Hanieh Goodarzi
No. 75, Azadi Alley, Cinema Felestin Alley, Ayatollah Kashani Ave
Borujerd Iran (Islamic Republic of) 6913718599 +98 66 4261 0119 h.goodarzi100@gmail.com Khoram-Abad University of Medical Sciences scientific Hanieh Goodarzi
No. 75, Azadi Alley, Cinema Felestin Alley, Ayatollah Kashani Ave
Borujerd Iran (Islamic Republic of) 6913718599 +98 66 4261 0119 h.goodarzi100@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Parents' willingness to participate in the study The gestational age of the neonate is 37 to 42 weeks Term babies weighing 2500 to 4000 grams without problems except for icter Apgar 8 to 10 at birth Breastfeeding and the onset of jaundice after the second da Total serum bilirubin 14 to 20 mg/dL The occurrence of jaundice in babies between days 2 and 7 Hematocrit percentage greater than 65% or hemoglobin greater than 20 2 days 7 days Both Congenital malformation or infection Need for blood transfusion Blood group incompatibility in baby and mother Having a history of skin allergy in the family Hemolytic icter P59.8 Neonatal jaundice from other specified causes Treatment - Drugs Treatment - Drugs Treatment - Devices First Intervention Group: This group will receive both phototherapy and bathing with Cichorium intybus extract. These Neonates were treated with sterile cotton before starting phototherapy and then for 2 days, once a day, after feeding at noon when phototherapy is stopped for health care and other cases, with 250 ml of Cichorium intybus extract. They bathe for 5 to 7 minutes. The room temperature is set at 24-28 degrees Celsius. Cichorium intybus extract is also heated to a temperature of 37.5 degrees Celsius. (Cichorium intybus refers to the aqueous extract of the leaves of this plant. The preparation of the aqueous extract of this medicinal plant is done daily in the laboratory in accordance with the principles of extraction by the pharmaceutical chemist under the supervision of the project's pharmacist. 50 grams of ground Cichorium intybus in 250 cc of water The distillate is soaked at laboratory temperature for 72 hours away from sunlight. Then it is smoothed with Whatman filter paper and prepared for intervention in disposable bottles with a capacity of half a liter. The extracts are stored in the treatment room of the hospital wards at temperature properly maintained and used on a daily basis). Second Intervention Group: This group will receive both phototherapy and bathing with Fumaria officinalis extract. These Neonates were first hospitalized using sterile cotton before starting phototherapy and then for 2 days, once a day, after feeding at noon, when phototherapy is stopped for health care and other cases, with 250 ml of Fumaria officinalis extract. They bathe for 5 to 7 minutes. The room temperature is set at 24-28 degrees Celsius. Fumaria officinalis refers to the aqueous extract of the leaves of this plant. The preparation of the aqueous extract of this medicinal plant is done daily in the laboratory by following the principles of extraction by a pharmaceutical chemist under the supervision of a project pharmacist. It is dried at room temperature and away from direct sunlight and is ground into powder using a mill. The powder obtained from Fumaria officinalis leaves is mixed with distilled water in a ratio of 1 to 9 (50 grams of powder in 450 cc of distilled water) and boiled for 10 to 15 minutes. Then the extract is filtered using Whatman paper and stored in colored glass until consumption. Control Group: This group receives only phototherapy (single, double and intense). Being single, double and severe also depends on the Neonate's bilirubin level. Thus, the high bilirubin level receives a severe type. Before starting phototherapy, all Neonates are examined for Coombs, glucose-6-phosphate dehydrogenase, total and direct bilirubin levels, and mother's and Neonate's Rh blood group. Blood bilirubin level. Timepoint: Before the intervention, 24 and 48 hours after the intervention. Method of measurement: Arterial blood sample and sent to the laboratory. Khoram Abad University of Medical Sciences Approved 2023-01-18 Khorramabad University of Medical Sciences ethics committee No. 75, Azadi Alley, Palestine Cinema Alley, Ayatollah Kashani Street Borujerd Lorestan Iran (Islamic Republic of)