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General information
2024-04-20, 1403/02/01
2024-09-22, 1403/07/01
2024-0409-2022 00:00:00
2024-12-21, 1403/10/01
2025-09-23, 1404/07/01
20242025-1209-2123 00:00:00
Protocol summary
Study aim
Investigating the efficacy of acupuncture in mild to moderate Crohn's disease (CD) and ulcerative colitis (UC) patients
Design
A randomized controlled trial with parallel groups on 56 patients. Sealedenvelope.com is used for stratified randomization
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Crohn's Disease Activity Index (for CD patients); Simple Clinical Colitis Activity Index (for UC patients)
General information
Reason for update
Mayo score changed to SCCAI
Acronym
IRCT registration information
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
Registration date
2024-03-18, 1402/12/28
Registrant information
Name
Behnam Bahadori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 8930
Email address
bahadorib4001@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of acupuncture on Inflammatory Bowel Disease patients
Public title
effect of acupuncture in inflammatory bowel disease
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 16 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice-Chancellor of Research and Technology, Qureshi Building, next to Hoizeh Cinema, Daneshgah Street, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-02-24, 1402/12/05
Ethics committee reference number
IR.MUMS.REC.1402.329
Health conditions studied
1
Description of health condition studied
crohn's disease
ICD-10 code
K50
ICD-10 code description
Crohn's disease [regional enteritis]
2
Description of health condition studied
ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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
Intervention groups
1
Description
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
Category
Treatment - Other
2
Description
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.