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IRCT20230902059321N1 IRCT 2023-10-18 Research Institute for Islamic and Complementary Medicine (RICM) Effect of Topical use of Chamomile oil and Dill oil on Abdominal Obesity Evaluation of the Effect of Topical use of Chamomile oil and Dill oil on Abdominal Obesity and Comparison with Placebo Group_ A Randomized Clinical Trial 2022-05-22 anticipated 60 Complete https://irct.ir/trial/72367 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into case and control groups by random allocation method. block randomization method and table of random numbers are used to prepare the random list. It is taken in the way that we design a random block with 6 rows and 10 columns and write down the number of 30 letters A and 30 letters B randomly in its houses. With the first patient's visit, the first cell from row 1 of column 1 is selected and assigned to the intervention or control group based on the letter in the patient's cell, and then we draw a line on the corresponding letter with the selected meaning. We do the same for the rest of the patients to finally reach the determined sample size. We made 60 cards and write letter A on 30 for intervention and on the other 30 letter B for the control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter (A or B) patients will be assigned to intervention or control group, Blinding description: The intervention group will receive a can of chamomile and dill oil, and the placebo group will receive a can of sesame oil. The medicine of both groups is ready to be delivered in similar packaging and in a can with dull color. The lid of the placebo oil can is smeared with chamomile and dill essential oil. 3 Obesity. Intervention 1: Intervention group: In the intervention group for 6 weeks, a combination of chamomile oil and dill oil once a day in the amount of 2 cc per square meter (in such a way that the entire abdominal area except for the radius of 2 centimeters around the navel (10 square centimeters) is completely lubricated and covered with a thin layer of oil) without massaging the area. After using the oil, cover the area with a plastic cover and have 30 minutes of aerobic activity (fast walking in such a way that the heart rate and breathing rate increase and sweating occurs) and the plastic cover is removed from the abdomen after the aerobic activity. Intervention 2: Control group: The control group received placebo oil for 6 weeks once a day in the amount of 2 cc per square meter (in such a way that the entire abdominal area except for the radius of 2 centimeters around the navel (10 square centimeters) was completely greased and covered with a thin layer of oil. be) used without massaging the area. After using the oil, cover the area with a plastic cover and have 30 minutes of aerobic activity (fast walking in such a way that the heart rate and breathing rate increase and sweating occurs) and the plastic cover is removed from the abdomen after the aerobic activity. 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 Maryam Bashiri
School of Traditional Medicine, No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1114733311 00 98 55580388 MaryamBashiri18@tahoo.com Iran University of Medical Sciences scientific Somayye Mahroozade
No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5558 0388 dr.mahroozade@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Women between 25 and 55 years Necessary cooperation in taking medicine Women suffering from abdominal obesity Waist circumference greater than 80 cm The possibility of following up patients Fill out a consent form by patients Not pregnant 25 years 55 years Female Not using another topical drug that interferes with the effect of the studied drug Use other weight loss methods Medical condition that prohibits aerobic exercise Patients who do professional sports activities Patients on a weight loss diet History of allergic reaction to topical use of Chamomile oil and Dill oil The presence of an active skin lesion in the study area Women who intend to become pregnant during the treatment period Pregnant women Patient dissatisfaction Hypothyroidism and uncontrolled diabetes mellitus History of using steroid drugs in the last three months E65-E68 Obesity and other hyperalimentation Treatment - Drugs Placebo Intervention group: In the intervention group for 6 weeks, a combination of chamomile oil and dill oil once a day in the amount of 2 cc per square meter (in such a way that the entire abdominal area except for the radius of 2 centimeters around the navel (10 square centimeters) is completely lubricated and covered with a thin layer of oil) without massaging the area. After using the oil, cover the area with a plastic cover and have 30 minutes of aerobic activity (fast walking in such a way that the heart rate and breathing rate increase and sweating occurs) and the plastic cover is removed from the abdomen after the aerobic activity. Control group: The control group received placebo oil for 6 weeks once a day in the amount of 2 cc per square meter (in such a way that the entire abdominal area except for the radius of 2 centimeters around the navel (10 square centimeters) was completely greased and covered with a thin layer of oil. be) used without massaging the area. After using the oil, cover the area with a plastic cover and have 30 minutes of aerobic activity (fast walking in such a way that the heart rate and breathing rate increase and sweating occurs) and the plastic cover is removed from the abdomen after the aerobic activity. Abdominal circumference size. Timepoint: At the beginning of the intervention, then every three weeks until the end of the intervention. Method of measurement: Tape measure. Abdominal subcutaneous fat thickness in three areas: the thickness of the horizontal skin fold at 3 cm from the navel and 1 cm below it on the right side, the thickness of the skin fold above the navel at the midpoint of the line between the breast and navel junction, the thickness of the left supra iliac skin fold above the iliac crest. In the left midaxillary line. Timepoint: At the beginning of the intervention, then every three weeks until the end of the intervention. Method of measurement: Skinfold Caliper. Body weight. Timepoint: At the beginning of the study and then every three weeks until the end of the study. Method of measurement: Digital weight scale. Body Mass Index. Timepoint: At the beginning of the study and then every three weeks until the end of the study. Method of measurement: Dividing people's weight (in kilograms) by the square of height (height times height in meters). Research Institute for Islamic and Complementary Medicine (RICM) Approved 2022-05-10 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences., Hemmat Highway Tehran Tehran Iran (Islamic Republic of)