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IRCT20231009059671N1 IRCT 2024-03-18 Mashhad University of Medical Sciences effect of acupuncture in inflammatory bowel disease Evaluation the effectiveness of acupuncture on Inflammatory Bowel Disease patients 2025-06-22 anticipated 56 Complete https://irct.ir/trial/73100 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method will be stratified, Crohn's and ulcerative colitis patients will be randomly and equally divided into intervention and control groups. A random sequence is generated using sealedenvelope.com based on permuted random blocks, and random numbers are printed and placed inside opaque sealed envelopes. The lid of the envelopes will be closed and its contents will not be visible from the outside. Then, first, the purpose of the study is explained to the person who meets the inclusion criteria, and if the person wishes, he signs the informed consent form and takes an envelope and then opens it, and based on the contents of the envelope, the person enters one of the two groups, Blinding description: Patients who are treated with acupuncture or sham acupuncture (sham) are blinded in such a way that needles are inserted into both groups under the same conditions, in the acupuncture group at the acupuncture points and at the depth of deqi, but in the sham group at Non-acupuncture points and superficially with a maximum depth of 0.2 cm Also, the evaluator and the analyst will be unaware of the grouping done. N/A Condition 1: crohn's disease. Condition 2: ulcerative colitis. Intervention 1: Intervention group: Patients in the intervention group receive acupuncture treatment twice a week for eight weeks and a total of 16 sessions. Each acupuncture session lasts about 30 minutes. The points include KID3(taixi), LIV3(taichong), ST25(tianshu), ST40(fenglong), ST36(zusanli), LI4(hegu), LI11(quchi), SP4(gongsun), SP6(sanyinjiao), SP9(yinlingchuan). ) , SP15(daheng) , BL18(ganshu) , BL20(pishu) , BL23(shenshu) , BL25(dachangshu) , PC6(neiguan) , HT7(shenmen) , CV4(guanyuan) , CV6(qihai) , CV9(shuifen) ), CV12(zhongwan), GV20(baihui), GV4(mingmen) with needles of size 0.25*40 and is inserted to the depth of deqi. Intervention 2: Control group: Patients in the control group, like the intervention group, receive 16 sham acupuncture sessions twice a week for eight weeks. Each session lasts about 30 minutes. The points with a distance from the acupuncture points in non-acupuncture point and non-meridian places are injected shallowly with the same number and size of needles as the intervention group. Yes - There is a plan to make this available What will be shared: Information about the disease of the participants and the results of the study in each of the groups When: The access period starts from the time the results are printed To whom: All researchers Conditions: To carry out research and treatment Where to obtain: Dr. Behnam Bahadori Acupuncture Clinic of Imam Reza Hospital, Mashhad 00989039825573 How to obtain: Review by the research team, review by the department and faculty, classification and data submission Comments:
public Behnam Bahadori
Faculty of Iranian and Complementary Medicine, kharazmi building, Mashhad university of medical sciences , Mashhad, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9188744880 +98 51 3884 8930 bahadorib4001@mums.ac.ir Mashhad University of Medical Sciences scientific Behnam Bahadori
Faculty of Iranian and Complementary Medicine, kharazmi building, Mashhad university of medical sciences , Mashhad, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9188744880 +98 51 3884 8930 bahadorib4001@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with Crohn's disease or ulcerative colitis who have been diagnosed for at least 6 months and are classified as mild to moderate according to the criteria of Crohn's disease activity index between 150 and 450 or simple clinical colitis activity index between 3 and 11 Consistency of drugs used in the last two months Sign informed consent 16 years 70 years Both disease or skin lesion at the location of acupuncture points using adalimumab history of abdominal surgery in the last 6 months serious systemic disease using anticoagulant or thrombolytic drugs history of skin allergy and needle or metal allergy known psychiatric illness severe extraintestinal complications related to inflammatory bowel disease such as severe skin problems or thromboembolic problems fistula, abscess, intestinal obstruction, intestinal perforation history of acupuncture pregnancy K50 K51 Crohn's disease [regional enteritis] Ulcerative colitis Treatment - Other Placebo Intervention group: Patients in the intervention group receive acupuncture treatment twice a week for eight weeks and a total of 16 sessions. Each acupuncture session lasts about 30 minutes. The points include KID3(taixi), LIV3(taichong), ST25(tianshu), ST40(fenglong), ST36(zusanli), LI4(hegu), LI11(quchi), SP4(gongsun), SP6(sanyinjiao), SP9(yinlingchuan). ) , SP15(daheng) , BL18(ganshu) , BL20(pishu) , BL23(shenshu) , BL25(dachangshu) , PC6(neiguan) , HT7(shenmen) , CV4(guanyuan) , CV6(qihai) , CV9(shuifen) ), CV12(zhongwan), GV20(baihui), GV4(mingmen) with needles of size 0.25*40 and is inserted to the depth of deqi Control group: Patients in the control group, like the intervention group, receive 16 sham acupuncture sessions twice a week for eight weeks. Each session lasts about 30 minutes. The points with a distance from the acupuncture points in non-acupuncture point and non-meridian places are injected shallowly with the same number and size of needles as the intervention group. Crohn's disease activity index. Timepoint: At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up). Method of measurement: CDAI Scoring. Simple clinical colitis activity index. Timepoint: At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up). Method of measurement: SCCAI Scoring. Inflammatory bowel disease questionnaire. Timepoint: At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up). Method of measurement: inflammatory bowel disease questionnaire-32. Stool calprotectin test. Timepoint: At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up). Method of measurement: stool sampling. CRP test. Timepoint: At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up). Method of measurement: Blood sampling. ESR test. Timepoint: At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up). Method of measurement: Blood sampling. Stool Exam. Timepoint: At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up). Method of measurement: stool sampling. Complete Blood Count. Timepoint: At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up). Method of measurement: Blood sampling. Mashhad University of Medical Sciences Approved 2024-02-24 Ethics committee of Mashhad University of Medical Sciences Vice-Chancellor of Research and Technology, Qureshi Building, next to Hoizeh Cinema, Daneshgah Street, Mashhad, Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)