Crohn's Disease RelapseNCT06553053
Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
A study testing "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group and "Nourishing spleen and kidney with warmth" Acupuncture Group in people with Crohn's Disease Relapse and Inflammatory Bowel Diseases, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial summary
The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Crohn's Disease Relapse, Inflammatory Bowel Diseases
- What is being tested?
- "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group and "Nourishing spleen and kidney with warmth" Acupuncture Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with clinical diagnosis consistent with CD;
- aged 16-75;
- patients in remission (CDAI < 150 and CRP < 5mg/l, or Faecal calprotectin < 50μg/g, or no ulcer under endoscopy);
- patients with frequent disease recurrences (≥2) in the past years;
- patients were not taking medication or were only taking one or more of the following drugs: [mesalazine (≤4g/d), prednisone (≤15mg/d), azathioprine (≤1mg/kg/d)] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-TNF-α, IL-12p40, α4β7);
- those who have never experienced acupuncture;
- patients signing informed consent.
Who cannot join
- patients who are recently pregnant or in pregnancy or lactation;
- patients with serious organic diseases;
- patients diagnosed as psychosis;
- patients who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
- severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
- there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
- patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
- there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Research Institute of Acupuncture and Meridian
Shanghai
Bao Chunhui, MD, PhD, +862164395973, baochunhui789@126.com
About this study
The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.
Read the detailed description
Acupuncture has been proven to be an effective and safe treatment for CD. In this trial, based on previous studies, which mainly treated CD from the perspective of spleen and stomach tonification, we explored the therapeutic effect of acupuncture in treating CD from the perspective of tonifying the Shaoyang pivot mechanism to enhance the therapeutic effect.Brain-gut axis dysfunction is one of the important pathogenic mechanisms of CD. This trial attempted to explore the therapeutic targets and efficacy mechanisms of acupuncture to enhance CD by analysing brain-gut axis multi-pathway indicators.
- Being tested
- "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group, "Nourishing spleen and kidney with warmth" Acupuncture Group
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture GroupOther
Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV12 and bilateral ST36 and GB41 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, GB41, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV4 and bilateral SP6 and GB34 were selected for moxibustion. These two groups are alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes.
"Nourishing spleen and kidney with warmth" Acupuncture GroupOther
Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3 and LI11 were selected for acupuncture and CV12 and bilateral ST36 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, SP4, KI3 and LI11 were selected for acupuncture and CV4 and bilateral SP6 were selected for moxibustion. These two groups are alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Receiving acupuncture with the function of "harmonizing Shaoyang, nourishing spleen and kidney with warmth" Receives: Other: "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group |
| Control group | Active comparator | Receiving acupuncture group with the function of "nourishing spleen and kidney with warmth" Receives: Other: "Nourishing spleen and kidney with warmth" Acupuncture Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of recurrences
Defined as CDAI > 150 and increase ≥ 70 points, or emergency, hospitalization and surgical events due to worsening of CD conditions, or need to adjust drug to control disease condition.
Measured: Week 52
Secondary outcomes (13)
Number of recurrences
Total number of recurrences. The median number will be counted for both groups.
Measured: Week 52
Time of recurrences
Time to first recurrence will be counted for both groups.
Measured: Week 52
Crohn's disease activity index （CDAI）score
The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.
Measured: Week 0, 6, 12, 24, 36 and 52
Patient Reported Outcome （PRO2）
The outcome is measured by level of abdominal pain (visual analogue scale, VAS) and number of diarrhoea in the past week.
Measured: Week 0, 6, 12, 24, 36 and 52
First laboratory tests
serum C-reactive protein (CRP)
Measured: Week 0, 6, 12, 24, 36 and 52
Second laboratory tests
erythrocyte sedimentation rate (ESR)
Measured: Week 0, 6, 12, 24, 36 and 52
Third laboratory tests
platelet count (PLT)
Measured: Week 0, 6, 12, 24, 36 and 52
Inflammatory bowel disease questionnaire (IBDQ)
The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.
Measured: Week 0, 12, 24, 36 and 52
Hospital anxiety and depression scale (HADS)
The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Measured: Week 0, 12, 24, 36 and 52
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52.
Measured: Week 0, 12, 24, 36 and 52
Colonoscopy or small bowel MR evaluation
measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score)
Measured: Week 0 and 52
Expectation of acupuncture treatment
measured by acupuncture treatment effectiveness expectation questionnaire
Measured: Week 0
Blind questionnaire
measured by patients guessing their grouping
Measured: Week 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start13 Aug 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Crohn's Disease RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital
- Responsible party
- Sponsor
- Investigators
- Bao Chunhui, MD, PhD, Principal investigator, Shanghai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553053
- Sponsor's protocol ID
- ZYS2024-04
- Status last verified
- Apr 2026
- First submitted
- 7 Aug 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dolinger M, Torres J, Vermeire S. Crohn's disease. Lancet. 2024 Mar 23;403(10432):1177-1191. doi: 10.1016/S0140-6736(23)02586-2. Epub 2024 Mar 1.
PubMed 38437854Roda G, Chien Ng S, Kotze PG, Argollo M, Panaccione R, Spinelli A, Kaser A, Peyrin-Biroulet L, Danese S. Crohn's disease. Nat Rev Dis Primers. 2020 Apr 2;6(1):22. doi: 10.1038/s41572-020-0156-2.
PubMed 32242028Greuter T, Vavricka SR. Extraintestinal manifestations in inflammatory bowel disease - epidemiology, genetics, and pathogenesis. Expert Rev Gastroenterol Hepatol. 2019 Apr;13(4):307-317. doi: 10.1080/17474124.2019.1574569. Epub 2019 Feb 20.
PubMed 30791773Ng SC, Leung WK, Shi HY, Li MK, Leung CM, Ng CK, Lo FH, Hui YT, Tsang SW, Chan YK, Loo CK, Chan KH, Hui AJ, Chow WH, Harbord M, Ching JY, Lee M, Chan V, Tang W, Hung IF, Ho J, Lao WC, Wong MT, Sze SF, Shan EH, Lam BC, Tong RW, Mak LY, Wong SH, Wu JC, Chan FK, Sung JJ. Epidemiology of Inflammatory Bowel Disease from 1981 to 2014: Results from a Territory-Wide Population-Based Registry in Hong Kong. Inflamm Bowel Dis. 2016 Aug;22(8):1954-60. doi: 10.1097/MIB.0000000000000846.
PubMed 27416041Zheng JJ, Zhu XS, Huangfu Z, Gao ZX, Guo ZR, Wang Z. Crohn's disease in mainland China: a systematic analysis of 50 years of research. Chin J Dig Dis. 2005;6(4):175-81. doi: 10.1111/j.1443-9573.2005.00227.x.
PubMed 16246226Kaplan GG. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150. Epub 2015 Sep 1.
PubMed 26323879Bonovas S, Fiorino G, Allocca M, Lytras T, Nikolopoulos GK, Peyrin-Biroulet L, Danese S. Biologic Therapies and Risk of Infection and Malignancy in Patients With Inflammatory Bowel Disease: A Systematic Review and Network Meta-analysis. Clin Gastroenterol Hepatol. 2016 Oct;14(10):1385-1397.e10. doi: 10.1016/j.cgh.2016.04.039. Epub 2016 May 14.
PubMed 27189910Esters P, Dignass A. Complementary therapies in inflammatory bowel diseases. Curr Drug Targets. 2014;15(11):1079-88. doi: 10.2174/1389450115666140903112802.
PubMed 25182607Qu YK, Zhu Y.Differential diagnosis and treatment of Crohn's disease based on the theory of
Bao C, Wu L, Wang D, Chen L, Jin X, Shi Y, Li G, Zhang J, Zeng X, Chen J, Liu H, Wu H. Acupuncture improves the symptoms, intestinal microbiota, and inflammation of patients with mild to moderate Crohn's disease: A randomized controlled trial. EClinicalMedicine. 2022 Feb 12;45:101300. doi: 10.1016/j.eclinm.2022.101300. eCollection 2022 Mar.
PubMed 35198926Gracie DJ, Guthrie EA, Hamlin PJ, Ford AC. Bi-directionality of Brain-Gut Interactions in Patients With Inflammatory Bowel Disease. Gastroenterology. 2018 May;154(6):1635-1646.e3. doi: 10.1053/j.gastro.2018.01.027. Epub 2018 Jan 31.
PubMed 29366841Gracie DJ, Hamlin PJ, Ford AC. The influence of the brain-gut axis in inflammatory bowel disease and possible implications for treatment. Lancet Gastroenterol Hepatol. 2019 Aug;4(8):632-642. doi: 10.1016/S2468-1253(19)30089-5. Epub 2019 May 20.
PubMed 31122802Fairbrass KM, Lovatt J, Barberio B, Yuan Y, Gracie DJ, Ford AC. Bidirectional brain-gut axis effects influence mood and prognosis in IBD: a systematic review and meta-analysis. Gut. 2022 Sep;71(9):1773-1780. doi: 10.1136/gutjnl-2021-325985. Epub 2021 Nov 1.
PubMed 34725197Pellissier S, Dantzer C, Mondillon L, Trocme C, Gauchez AS, Ducros V, Mathieu N, Toussaint B, Fournier A, Canini F, Bonaz B. Relationship between vagal tone, cortisol, TNF-alpha, epinephrine and negative affects in Crohn's disease and irritable bowel syndrome. PLoS One. 2014 Sep 10;9(9):e105328. doi: 10.1371/journal.pone.0105328. eCollection 2014.
PubMed 25207649Bonaz B, Sinniger V, Hoffmann D, Clarencon D, Mathieu N, Dantzer C, Vercueil L, Picq C, Trocme C, Faure P, Cracowski JL, Pellissier S. Chronic vagus nerve stimulation in Crohn's disease: a 6-month follow-up pilot study. Neurogastroenterol Motil. 2016 Jun;28(6):948-53. doi: 10.1111/nmo.12792. Epub 2016 Feb 27.
PubMed 26920654
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
- ClinicalTrials.gov ID
- NCT06553053
- Acronym / sponsor ID
- ZYS2024-04
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Collaborators
- Ruijin Hospital
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.
Detailed description
Acupuncture has been proven to be an effective and safe treatment for CD. In this trial, based on previous studies, which mainly treated CD from the perspective of spleen and stomach tonification, we explored the therapeutic effect of acupuncture in treating CD from the perspective of tonifying the Shaoyang pivot mechanism to enhance the therapeutic effect.Brain-gut axis dysfunction is one of the important pathogenic mechanisms of CD. This trial attempted to explore the therapeutic targets and efficacy mechanisms of acupuncture to enhance CD by analysing brain-gut axis multi-pathway indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture GroupReceiving acupuncture with the function of "harmonizing Shaoyang, nourishing spleen and kidney with warmth" |
| Control group | Active comparator | Other: "Nourishing spleen and kidney with warmth" Acupuncture GroupReceiving acupuncture group with the function of "nourishing spleen and kidney with warmth" |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- patients with clinical diagnosis consistent with CD;
- aged 16-75;
- patients in remission (CDAI < 150 and CRP < 5mg/l, or Faecal calprotectin < 50μg/g, or no ulcer under endoscopy);
- patients with frequent disease recurrences (≥2) in the past years;
- patients were not taking medication or were only taking one or more of the following drugs: [mesalazine (≤4g/d), prednisone (≤15mg/d), azathioprine (≤1mg/kg/d)] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-TNF-α, IL-12p40, α4β7);
Key exclusion criteria (8 listed)
- patients who are recently pregnant or in pregnancy or lactation;
- patients with serious organic diseases;
- patients diagnosed as psychosis;
- patients who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
- severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture GroupPatients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV12 and bilateral ST36 and GB41 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, GB41, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV4 and bilateral SP6 and GB34 were selected for moxibustion. These two groups are alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes. | Other | Experimental Group |
| "Nourishing spleen and kidney with warmth" Acupuncture GroupPatients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3 and LI11 were selected for acupuncture and CV12 and bilateral ST36 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, SP4, KI3 and LI11 were selected for acupuncture and CV4 and bilateral SP6 were selected for moxibustion. These two groups are alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes. | Other | Control group |
Primary outcome
The proportion of recurrences
Time frame: Week 52
Defined as CDAI > 150 and increase ≥ 70 points, or emergency, hospitalization and surgical events due to worsening of CD conditions, or need to adjust drug to control disease condition.
13 secondary outcomes
Number of recurrences
Time frame: Week 52
Time of recurrences
Time frame: Week 52
Crohn's disease activity index （CDAI）score
Time frame: Week 0, 6, 12, 24, 36 and 52
Patient Reported Outcome （PRO2）
Time frame: Week 0, 6, 12, 24, 36 and 52
First laboratory tests
Time frame: Week 0, 6, 12, 24, 36 and 52
Second laboratory tests
Time frame: Week 0, 6, 12, 24, 36 and 52
Third laboratory tests
Time frame: Week 0, 6, 12, 24, 36 and 52
Inflammatory bowel disease questionnaire (IBDQ)
Time frame: Week 0, 12, 24, 36 and 52
Hospital anxiety and depression scale (HADS)
Time frame: Week 0, 12, 24, 36 and 52
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: Week 0, 12, 24, 36 and 52
Colonoscopy or small bowel MR evaluation
Time frame: Week 0 and 52
Expectation of acupuncture treatment
Time frame: Week 0
Blind questionnaire
Time frame: Week 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 38437854Dolinger M, Torres J, Vermeire S. Crohn's disease. Lancet. 2024 Mar 23;403(10432):1177-1191. doi: 10.1016/S0140-6736(23)02586-2. Epub 2024 Mar 1.
- Background: PubMed 32242028Roda G, Chien Ng S, Kotze PG, Argollo M, Panaccione R, Spinelli A, Kaser A, Peyrin-Biroulet L, Danese S. Crohn's disease. Nat Rev Dis Primers. 2020 Apr 2;6(1):22. doi: 10.1038/s41572-020-0156-2.
- Background: PubMed 30791773Greuter T, Vavricka SR. Extraintestinal manifestations in inflammatory bowel disease - epidemiology, genetics, and pathogenesis. Expert Rev Gastroenterol Hepatol. 2019 Apr;13(4):307-317. doi: 10.1080/17474124.2019.1574569. Epub 2019 Feb 20.
- Background: PubMed 27416041Ng SC, Leung WK, Shi HY, Li MK, Leung CM, Ng CK, Lo FH, Hui YT, Tsang SW, Chan YK, Loo CK, Chan KH, Hui AJ, Chow WH, Harbord M, Ching JY, Lee M, Chan V, Tang W, Hung IF, Ho J, Lao WC, Wong MT, Sze SF, Shan EH, Lam BC, Tong RW, Mak LY, Wong SH, Wu JC, Chan FK, Sung JJ. Epidemiology of Inflammatory Bowel Disease from 1981 to 2014: Results from a Territory-Wide Population-Based Registry in Hong Kong. Inflamm Bowel Dis. 2016 Aug;22(8):1954-60. doi: 10.1097/MIB.0000000000000846.
- Background: PubMed 16246226Zheng JJ, Zhu XS, Huangfu Z, Gao ZX, Guo ZR, Wang Z. Crohn's disease in mainland China: a systematic analysis of 50 years of research. Chin J Dig Dis. 2005;6(4):175-81. doi: 10.1111/j.1443-9573.2005.00227.x.
- Background: PubMed 26323879Kaplan GG. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150. Epub 2015 Sep 1.
- Background: PubMed 27189910Bonovas S, Fiorino G, Allocca M, Lytras T, Nikolopoulos GK, Peyrin-Biroulet L, Danese S. Biologic Therapies and Risk of Infection and Malignancy in Patients With Inflammatory Bowel Disease: A Systematic Review and Network Meta-analysis. Clin Gastroenterol Hepatol. 2016 Oct;14(10):1385-1397.e10. doi: 10.1016/j.cgh.2016.04.039. Epub 2016 May 14.
- Background: PubMed 25182607Esters P, Dignass A. Complementary therapies in inflammatory bowel diseases. Curr Drug Targets. 2014;15(11):1079-88. doi: 10.2174/1389450115666140903112802.
- BackgroundQu YK, Zhu Y.Differential diagnosis and treatment of Crohn's disease based on the theory of
- Background: PubMed 35198926Bao C, Wu L, Wang D, Chen L, Jin X, Shi Y, Li G, Zhang J, Zeng X, Chen J, Liu H, Wu H. Acupuncture improves the symptoms, intestinal microbiota, and inflammation of patients with mild to moderate Crohn's disease: A randomized controlled trial. EClinicalMedicine. 2022 Feb 12;45:101300. doi: 10.1016/j.eclinm.2022.101300. eCollection 2022 Mar.
- Background: PubMed 29366841Gracie DJ, Guthrie EA, Hamlin PJ, Ford AC. Bi-directionality of Brain-Gut Interactions in Patients With Inflammatory Bowel Disease. Gastroenterology. 2018 May;154(6):1635-1646.e3. doi: 10.1053/j.gastro.2018.01.027. Epub 2018 Jan 31.
- Background: PubMed 31122802Gracie DJ, Hamlin PJ, Ford AC. The influence of the brain-gut axis in inflammatory bowel disease and possible implications for treatment. Lancet Gastroenterol Hepatol. 2019 Aug;4(8):632-642. doi: 10.1016/S2468-1253(19)30089-5. Epub 2019 May 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bao Chunhui, MD, PhD principal investigator
Shanghai University of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group and "Nourishing spleen and kidney with warmth" Acupuncture Group in people with Crohn's Disease Relapse and Inflammatory Bowel Diseases, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bao Chunhui, MD, PhD (+862164395973, baochunhui789@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of recurrences (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06553053, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.