ArticleBMJ open gastroenterology2021
Treatment-refractory ulcerative colitis responsive to indigo naturalis.
Article in BMJ open gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02442960 (An Open-Label, Dose-Escalation Phase Ib Study Evaluating the Safety and Preliminary Efficacy of Oral SA100 in the Treatment of Patients With Mild, Moderate or Severe Ulcerative Colitis), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label, Dose-Escalation Phase Ib Study Evaluating the Safety and Preliminary Efficacy of Oral SA100 in the Treatment of Patients With Mild, Moderate or Severe Ulcerative Colitis
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.
- Indigo naturalis for inflammatory bowel disease: evidence from animal studies and molecular mechanisms.Frontiers in pharmacology · 2025Pooled it
- Herbal Medicines for the Treatment of Active Ulcerative Colitis: A Systematic Review and Meta-Analysis.Nutrients · 2024Pooled it
- Aryl hydrocarbon receptor pharmacology-mechanisms, ligands, and therapeutic potential.Pharmacological reviews · 2026Review
- Aryl Hydrocarbon Receptor in Health and Disease.MedComm · 2025Review
- Evaluation of Indigo Naturalis Prepared Using a Novel Method: Therapeutic Effects on Experimental Ulcerative Colitis in Mice.Pharmaceutics · 2025Article
- Indigo naturalis‑associated ischemic injury of colorectal mucosa: A case series study.Experimental and therapeutic medicine · 2025Article
- Targeting CD4+ T cells through gut microbiota: therapeutic potential of traditional Chinese medicine in inflammatory bowel disease.Frontiers in cellular and infection microbiology · 2025Review
- Review
- Exploring the Anti-Inflammatory Effect of Tryptanthrin by Regulating TLR4/MyD88/ROS/NF-κB, JAK/STAT3, and Keap1/Nrf2 Signaling Pathways.ACS omega · 2024Article
- Aryl Hydrocarbon Receptor Signalling in the Control of Gut Inflammation.International journal of molecular sciences · 2024Review
- Ferroptosis in the colon epithelial cells as a therapeutic target for ulcerative colitis.Journal of gastroenterology · 2023Article
- The interplay between the microbiota, diet and T regulatory cells in the preservation of the gut barrier in inflammatory bowel disease.Frontiers in microbiology · 2023Review
- Complementary medicines used in ulcerative colitis and unintended interactions with cytochrome P450-dependent drug-metabolizing enzymes.Turkish journal of medical sciences · 2022Review
- Review
- Curcumin-QingDai Combination as Treatment for Moderate-Severe Ulcerative Colitis.Case reports in gastroenterologyArticle
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIndigo naturalis (IN) is an herbal medicine that has been used for ulcerative colitis with an unclear mechanism of action. Indigo and indirubin, its main constituents, are ligands of the aryl hydrocarbon receptor (AhR). We assessed the safety, efficacy, and colon AhR activity of IN given orally to patients with treatment-refractory ulcerative colitis. The role of AhR in IN benefit was further evaluated with an AhR antagonist in a murine colitis model.
methodsThis open-label, dose-escalation study sequentially treated 11 patients with ulcerative colitis with either IN 500 mg/day or 1.5 g/day for 8 weeks, followed by a 4-week non-treatment period. The primary efficacy endpoint was clinical response at week 8, assessed by total Mayo score. Secondary endpoints included clinical remission, Ulcerative Colitis Endoscopic Index of Severity, quality of life, and colon AhR activity measured by cytochrome P450 1A1 (CYP1A1) RNA expression.
resultsTen of 11 (91%) patients, including 8/9 (89%) with moderate-to-severe disease, achieved a clinical response. Among these 10 patients, all had failed treatment with 5-aminosalicylic acid, 8 patients with a tumour necrosis factor (TNF)-alpha inhibitor, and 6 patients with TNF-alpha inhibitor and vedolizumab. Five patients were corticosteroid dependent. Clinical response was observed in all five patients who had been recommended for colectomy. Three patients achieved clinical remission. All patients experienced improved endoscopic severity and quality of life. Four weeks after treatment completion, six patients had worsened partial Mayo scores. Four patients progressed to colectomy after study completion. Colon CYP1A1 RNA expression increased 12 557-fold at week 8 among six patients evaluated. No patient discontinued IN due to an adverse event. Concomitant administration of 3-methoxy-4-nitroflavone, an AhR antagonist, in a murine colitis model abrogated the benefit of IN.
conclusionIN is a potentially effective therapy for patients with treatment-refractory ulcerative colitis. This benefit is likely through AhR activation. TRIAL REGISTRATION NUMBER: NCT02442960.
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