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IRCT20171007036614N3 IRCT 2023-06-27 Tehran University of Medical Sciences effects of acupuncture and embedding in overweight patients Evaluating the effects of acupuncture and embedding on anthropometric indices and inflammation biomarkers in overweight patients: a randomized placebo-controlled trial 2023-09-23 anticipated 150 Complete https://irct.ir/trial/64184 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are randomly divided into 3 groups by the block randomization method (ABA, ACB, BAC, BCA, CAB, CBA). group A receives acupuncture, group B embedding, and group C placebo of acupuncture. A number from 1 to 6 will be assigned to each block. To achieve sample size, 50 numbers (blocks) will be generated by an online random number generator and participants will be assigned to the groups randomly, Blinding description: Patients will be randomly divided into 3 groups. Acupuncture and its placebo is similar and patients can not identify them but embedding is different. So totally blindness for patients and physician is not possible. Outcomes will be measured by a third party who is not aware about group of participants and type of intervention. 3 Obesity. Intervention 1: Intervention group: Acupuncture. To perform acupuncture, stimulation of st40, st36, st44, lv2, lv3, st25, st26, st27, ren4, ren6, ren10, ren12, sp13-15, gb26, st32, Li13 acupoints will be performed. Acupuncture with disposable steel needles of quanqi brand size 25 x 40 are selected in acupoints based on the predominant obesity syndrome, which is sp qi def and damp. The needles are inserted vertically. In the abdominal, thigh and arm, depending on the patient's body, it is inserted between 1 to 2.5 cm, and in other areas, such as between the fingers and toes, 5 to 7 mm. Due to the predominant syndrome of patients in places such as st40, st36, st25, sp15, the tonification technique is used and in other points even technique are used. The needles stay in place for about 20 minutes. Some points such as st25, ren12, ren4, 26 gb are connected to the electrode and after 20 minutes the device is turned off, the connection is disconnected and the needles are removed. The frequency of the device will be between 10-15 Hz, depending on the patient's tolerance. The electrode will be from KWD brand and the same for patients. Each participant will receive acupuncture protocol twice a week for 4 weeks and then once a week until the end of the eighth week. Intervention 2: Intervention group: Embedding. Stimulation of St24-26, Ren4, Ren6, Ren10, Ren12, Kd17 in sterile condition using absorbable sutures each 3 weeks for 3 sessions (weeks 0, 3 and 6 of study) will be performed. Intervention 3: Control group: Acupuncture placebo. For acupuncture placebo, disposable 18 x 20 needles of quanqi brand are used. Points that are not acupoints and are at least 1 cm away from the acupoints will be selected carefully. The needle penetrates the skin up to 2 mm and even less in the hand area (only a small contact) and tries not to have a manipulation process and the needle is not deeper. To electro simulate, needles are attached to the device, the device is turned on but the patient does not receive a frequency. For this group, the needles stay in the body for 20 minutes and then come out. Each participant will visit twice a week for up to 4 weeks and then once a week until the end of the eighth week. Yes - There is a plan to make this available What will be shared: Gathered data will be analyzed and then published. When: After publishing study To whom: Everyone (depending on the journal policies) Conditions: Published article will be public. Where to obtain: The journal that the paper is published in. How to obtain: Just sending Email to corresponding author. Comments:
public Mohammad Sadegh Adel Mehraban
Taleqani St., Ahmadie Clinic
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 4535 sadeghadel@gmail.com Tehran University of Medical Sciences scientific Amirhooman Kazemi
Taleqani St., Ahmadie clinic
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 4535 amirhoomank@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age 25-65 years old Overweight patients (BMI 25-29.9) 25 years 65 years Both Pregnancy Lactation Any significant underlying disease (pulmonary, cardiovascular, liver, cancer, etc.) Diet within the past 6 months E66 Overweight and obesity Treatment - Other Treatment - Other Placebo Intervention group: Acupuncture. To perform acupuncture, stimulation of st40, st36, st44, lv2, lv3, st25, st26, st27, ren4, ren6, ren10, ren12, sp13-15, gb26, st32, Li13 acupoints will be performed. Acupuncture with disposable steel needles of quanqi brand size 25 x 40 are selected in acupoints based on the predominant obesity syndrome, which is sp qi def and damp. The needles are inserted vertically. In the abdominal, thigh and arm, depending on the patient's body, it is inserted between 1 to 2.5 cm, and in other areas, such as between the fingers and toes, 5 to 7 mm. Due to the predominant syndrome of patients in places such as st40, st36, st25, sp15, the tonification technique is used and in other points even technique are used. The needles stay in place for about 20 minutes. Some points such as st25, ren12, ren4, 26 gb are connected to the electrode and after 20 minutes the device is turned off, the connection is disconnected and the needles are removed. The frequency of the device will be between 10-15 Hz, depending on the patient's tolerance. The electrode will be from KWD brand and the same for patients. Each participant will receive acupuncture protocol twice a week for 4 weeks and then once a week until the end of the eighth week. Intervention group: Embedding. Stimulation of St24-26, Ren4, Ren6, Ren10, Ren12, Kd17 in sterile condition using absorbable sutures each 3 weeks for 3 sessions (weeks 0, 3 and 6 of study) will be performed. Control group: Acupuncture placebo. For acupuncture placebo, disposable 18 x 20 needles of quanqi brand are used. Points that are not acupoints and are at least 1 cm away from the acupoints will be selected carefully. The needle penetrates the skin up to 2 mm and even less in the hand area (only a small contact) and tries not to have a manipulation process and the needle is not deeper. To electro simulate, needles are attached to the device, the device is turned on but the patient does not receive a frequency. For this group, the needles stay in the body for 20 minutes and then come out. Each participant will visit twice a week for up to 4 weeks and then once a week until the end of the eighth week. Weight. Timepoint: Before treatment, after 4 weeks, and after 8 weeks. Method of measurement: Digital scale. Body mass index. Timepoint: Before treatment, after 4 weeks, and after 8 weeks. Method of measurement: Divide weight by height squared. IL-6. Timepoint: Before treatment and after 8 weeks. Method of measurement: ELISA. IL-10. Timepoint: Before treatment and after 8 weeks. Method of measurement: ELISA. Tehran University of Medical Sciences Approved 2023-03-14 Ethics committee/institute of Pharmaceuticals Sciences -Tehran University of Medical Sciences Enqelab St. Tehran Tehran Iran (Islamic Republic of)