Clinical Study on the Integration of Traditional Chinese Medicine Virtual Hanging Therapy With Me… (NCT07113795) | Clinical Trial Compass
By InvitationEarly Phase 1
Clinical Study on the Integration of Traditional Chinese Medicine Virtual Hanging Therapy With Mesenchymal Stem Cells for the Treatment of Crohn's Disease-Associated Anal Fistula.
China90 participantsStarted 2022-07-01
Plain-language summary
To evaluate the efficacy and safety of TCM virtual hanging therapy combined with mesenchymal stem cellsin the treatment of CD anal fistula. To establish the standard of clinical diagnosis and treatment and thestandard procedure of operation for the treatment of CD anal fistula by virtual hanging therapy combinedwith mesenchymal stem cells.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Signed informed consent form.
Diagnosis of Crohn's disease (CD) confirmed at least 6 months prior to screening, based on the Chinese Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing).
Crohn's Disease Activity Index (CDAI) score ≤220, indicating inactive or mildly active CD.
Presence of complex anal fistula confirmed by clinical and MRI evaluation.
Age 18-60 years (inclusive), regardless of sex.
Negative serum/urine pregnancy test for women of childbearing potential; all participants must agree to use effective contraception during and for 6 months after the trial.
Good general health status confirmed by medical history and relevant examinations.
Exclusion Criteria:
CDAI \>220 or requiring immediate treatment for active CD.
Patients with rectal/anal stenosis or active proctitis (due to procedural limitations).
Presence of abscess \>2 cm unless treated ≥2 weeks prior to the trial.
History of fistula surgery (except drainage or seton placement), concurrent need for perianal surgery unrelated to fistula, or anticipated need for such surgery within 24 weeks post-treatment.
Systemic steroid therapy within 4 weeks prior to screening.
Abnormal laboratory results:
Liver function: Total bilirubin ≥1.5×ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5×ULN.
Renal function: Creatinine clearance \<60 mL/min or serum creatinine ≥1.5×ULN (measured or calculated by Cockcroft-Gault formula).
Curren…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CD anal fistula healing rate
Timeframe: From enrollment to the end of treatment at 24 weeks
Trial details
NCT IDNCT07113795
SponsorThe Anorectal Center of Nanjing Hospital of Traditional Chinese Medicine