Protocol summary
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Study aim
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Investigating the efficacy of acupuncture in mild to moderate Crohn's disease (CD) and ulcerative colitis (UC) patients
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Design
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A randomized controlled trial with parallel groups on 56 patients. Sealedenvelope.com is used for stratified randomization
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Settings and conduct
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Patients who meet the inclusion criteria first sign the informed consent form and then are randomly divided into one of two intervention or control groups. In both groups, the needles are inserted into the skin, with the difference that in the intervention group, needling was done in acupoints with deqi depth, but in the control group, the needles were inserted superficially in non-acupoints, therefore the patients of both groups feel the needle entering the body. By referring to the acupuncture clinic of Imam Reza (AS) Mashhad University Hospital, patients receive a total of 16 acupuncture sessions during 8 weeks and 2 sessions per week. Scoring of disease severity and tests and quality of life questionnaire are measured at the beginning of the study, after the completion of the sessions and 8 weeks after that.
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Participants/Inclusion and exclusion criteria
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Patients diagnosed with CD or UC who have been diagnosed for at least 6 months and are in the mild to moderate category according to the criteria of Crohn's disease activity index between 150 and 450 or simple clinical colitis activity index between 3 and 11 and whose medications have been taken for two months The past has been unchanged. and do not have a history of acupuncture
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Intervention groups
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In the intervention group, real acupuncture is performed in the patients, and in the control group, sham acupuncture is performed in the form of superficial needle insertion in non-acupuncture points.
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Main outcome variables
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Crohn's Disease Activity Index (for CD patients); Simple Clinical Colitis Activity Index (for UC patients)
General information
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Reason for update
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Mayo score changed to SCCAI
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231009059671N1
Registration date:
2024-03-18, 1402/12/28
Registration timing:
prospective
Last update:
2024-10-28, 1403/08/07
Update count:
3
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Registration date
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2024-03-18, 1402/12/28
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2024-09-22, 1403/07/01
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Expected recruitment end date
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2025-09-23, 1404/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation the effectiveness of acupuncture on Inflammatory Bowel Disease patients
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Public title
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effect of acupuncture in inflammatory bowel disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 16 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-02-24, 1402/12/05
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Ethics committee reference number
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IR.MUMS.REC.1402.329
Health conditions studied
1
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Description of health condition studied
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crohn's disease
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ICD-10 code
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K50
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ICD-10 code description
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Crohn's disease [regional enteritis]
2
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Description of health condition studied
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ulcerative colitis
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ICD-10 code
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K51
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ICD-10 code description
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Ulcerative colitis
Primary outcomes
1
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Description
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crohn's disease activity index
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Timepoint
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At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up)
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Method of measurement
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CDAI Scoring
2
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Description
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Simple clinical colitis activity index
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Timepoint
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At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up)
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Method of measurement
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SCCAI Scoring
Secondary outcomes
1
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Description
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inflammatory bowel disease questionnaire
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Timepoint
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At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up)
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Method of measurement
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inflammatory bowel disease questionnaire-32
2
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Description
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stool calprotectin test
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Timepoint
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At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up)
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Method of measurement
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stool sampling
3
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Description
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CRP test
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Timepoint
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At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up)
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Method of measurement
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Blood sampling
4
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Description
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ESR test
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Timepoint
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At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up)
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Method of measurement
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Blood sampling
5
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Description
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Stool Exam
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Timepoint
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At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up)
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Method of measurement
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stool sampling
6
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Description
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Complete Blood Count
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Timepoint
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At the beginning of the study (before the start of the intervention), 8 weeks later (ending the intervention), 16 weeks later (follow-up)
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Method of measurement
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Blood sampling
Intervention groups
1
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Description
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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
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Information about the disease of the participants and the results of the study in each of the groups
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When the data will become available and for how long
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The access period starts from the time the results are printed
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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To carry out research and treatment
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From where data/document is obtainable
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Dr. Behnam Bahadori
Acupuncture Clinic of Imam Reza Hospital, Mashhad
00989039825573
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What processes are involved for a request to access data/document
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Review by the research team, review by the department and faculty, classification and data submission
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Comments
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