Trial reportJournal of gastroenterology2020
Indigo naturalis is effective even in treatment-refractory patients with ulcerative colitis: a post hoc analysis from the INDIGO study.
Trial report in Journal of gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 35 citations in OpenAlex.
- Pharmacokinetics and Acute Safety Evaluation of Tryptanthrin, A Bioactive Constituent of Indigo naturalis, Following Intravenous Administration in Mice.Journal of applied toxicology : JAT · 2026Article
- Complementary medicines and ginseng for inflammatory bowel disease-rooted in science, but will it bear fruit?World journal of gastroenterology · 2025Article
- Evaluation of Indigo Naturalis Prepared Using a Novel Method: Therapeutic Effects on Experimental Ulcerative Colitis in Mice.Pharmaceutics · 2025Article
- Modulation of blood-tumor barrier transcriptional programs improves intratumoral drug delivery and potentiates chemotherapy in GBM.Science advances · 2025Article
- Selected Use of Complementary and Alternative Medicine (CAM) Agents in IBD.Current gastroenterology reports · 2025Review
- Review
- Clinical outcomes of patients with remitting ulcerative colitis after discontinuation of indigo naturalis.Scientific reports · 2024Article
- Ferroptosis in the colon epithelial cells as a therapeutic target for ulcerative colitis.Journal of gastroenterology · 2023Article
- Activation of the aryl hydrocarbon receptor inhibits the development of experimental autoimmune pancreatitis through IL-22-mediated signaling pathways.Clinical and experimental immunology · 2023Article
- Reviewing not Homer's Iliad, but "Kai Bao Ben Cao": indigo dye-the past, present, and future.Intestinal research · 2023Article
- Mechanism of Qingchang Suppository on repairing the intestinal mucosal barrier in ulcerative colitis.Frontiers in pharmacology · 2023Review
- A primer on common supplements and dietary measures used by patients with inflammatory bowel disease.Therapeutic advances in chronic disease · 2023Review
- Topical application of indigo-plant leaves extract enhances healing of skin lesion in an excision wound model in rats.Journal of applied biomedicine · 2022Article
- Ban-Lan-Gen Granule Alleviates Dextran Sulfate Sodium-Induced Chronic Relapsing Colitis in Mice via Regulating Gut Microbiota and Restoring Gut SCFA Derived-GLP-1 Production.Journal of inflammation research · 2022Article
- Network Pharmacology and Molecular Docking Analysis on Molecular Mechanism of Qingzi Zhitong Decoction in the Treatment of Ulcerative Colitis.Frontiers in pharmacology · 2022Article
- Treatment-refractory ulcerative colitis responsive to indigo naturalis.BMJ open gastroenterology · 2021Article
- Review
- Review
- Exploring the Mechanism of Indigo Naturalis in the Treatment of Ulcerative Colitis Based on TLR4/MyD88/NF-κB Signaling Pathway and Gut Microbiota.Frontiers in pharmacology · 2021Article
- A Comprehensive Review of the Chemistry, Pharmacokinetics, Pharmacology, Clinical Applications, Adverse Events, and Quality Control of Indigo Naturalis.Frontiers in pharmacology · 2021Review
Corrections and comments
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Authors and funding
22 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe recently reported the efficacy of indigo naturalis (IN) in patients with active ulcerative colitis (UC) in a randomized controlled trial (INDIGO study). However, few studies have been conducted to investigate whether IN is effective even in treatment-refractory cases, such as in those with steroid dependency and anti-TNF refractoriness.
methodsIn the INDIGO study, 86 patients with active UC were randomly assigned to an IN group (0.5-2.0 g daily) or placebo group. The rate of clinical response (CR), mucosal healing (MH), and change in fecal calprotectin (FCP) levels was compared between refractory [patients with steroid-dependent disease, previous use of anti-TNF-α, and concomitant use of immunomodulators (IM)] and non-refractory patients. We also analyzed factors predicting CR and MH at week 8.
resultsThe rates of CR of IN group were significantly higher than placebo group, even in patients with steroid-dependent disease (p < 0.001), previous use of anti-TNF-α (p = 0.002), and concomitant use of IM (p = 0.013). The rates of MH in IN group were significantly higher than in placebo group in patients with steroid-dependent disease (p = 0.009). In the IN group, median FCP levels, at week 8, were significantly lower than baseline in patients with steroid-dependent disease and patients with the previous use of anti-TNF-α (p < 0.001, respectively). Multivariate analysis indicated that the previous use of anti-TNF-α was not a predictive factor for CR and MH at week 8.
conclusionsIn a sub-analysis of data from a randomized placebo-controlled trial, we found that IN may be useful even in patients with steroid-dependent disease and patients with the previous use of anti-TNF-α.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.