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NCT06667934
Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis
Phase 1, PHASE2 trial testing Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night in Ulcerative Colitis (UC) in 60 participants. Not yet recruiting.
1 May 2025
Quick facts
| Lead sponsor | The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 30 October 2024 |
| Primary completion | 1 May 2025 |
| Estimated completion | 1 May 2025 |
Drugs / interventions tested
- Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night — full drug profile →
- Methalazine suppository was given rectally once a day — full drug profile →
Conditions studied
- Ulcerative Colitis (UC) — all drugs for Ulcerative Colitis (UC) →
Sponsor
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Who can join
Adults 18 to 65, any sex, with Ulcerative Colitis (UC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The exact efficacy of Zuoqing SAN enema in the treatment of Ulcerative colitis (UC) has been clinically verified. In this study, Zuoqing SAN was used to treat UC patients with large intestine damp-heat syndrome, and the traditional chinese medicine (TCM) syndrome type was large intestine damp-heat syndrome. The changes of symptoms and signs of patients before and after treatment were observed and compared, and the clinical efficacy of Zuoqing SAN in the treatment of UC large intestine damp-heat syndrome was evaluated by combining the changes of patients' symptoms, related blood indicators, improved Mayo total score, overall syndrome efficacy, clinical comprehensive efficacy and other aspects. By replicating the rat UC model, the effects of Zuoqing SAN on general survival state, colonic gross appearance and histopathological changes, related inflammatory factors, peroxisome proliferator-activated receptor γ (PPAR-γ) /nuclear factor kappa-B（NF-κB) /signal transducerand activator of transcription 1 (STAT1) pathway, macrophage M1, M2 phenotype and microangiogenesis were observed in UC rats. Thus, the specific mechanism of Zuoqing SAN in the treatment of UC was revealed. In this study, the therapeutic effect of Zuoqing Powder on UC was investigated through clinical and animal experiments, and the specific mechanism of action was studied.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06667934
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Other The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06667934 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Last refreshed: 31 October 2024
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