Trial reportPloS one2020
Efficacy and safety of short-term therapy with indigo naturalis for ulcerative colitis: An investigator-initiated multicenter double-blind clinical trial.
Trial report in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 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
- Pharmacokinetics and Acute Safety Evaluation of Tryptanthrin, A Bioactive Constituent of Indigo naturalis, Following Intravenous Administration in Mice.Journal of applied toxicology : JAT · 2026Article
- Defined human Clostridia consortia reverse colitis via dual effects of tryptophan metabolites on microbiota and immunity.Cell host & microbe · 2026Article
- Aryl hydrocarbon receptor pharmacology-mechanisms, ligands, and therapeutic potential.Pharmacological reviews · 2026Review
- The aryl hydrocarbon receptor: structure, signaling, physiology and pathology.Signal transduction and targeted therapy · 2026Review
- Emerging role of Janus kinase inhibitors in ulcerative colitis management.World journal of gastrointestinal pharmacology and therapeutics · 2025Review
- Braking the system: the aryl hydrocarbon receptor controls monocytes in homeostasis.The Journal of clinical investigation · 2025Article
- Article
- The aryl hydrocarbon receptor: a rehabilitated target for therapeutic immune modulation.Nature reviews. Drug discovery · 2025Review
- Complementary medicines and ginseng for inflammatory bowel disease-rooted in science, but will it bear fruit?World journal of gastroenterology · 2025Article
- Indigo naturalis‑associated ischemic injury of colorectal mucosa: A case series study.Experimental and therapeutic medicine · 2025Article
- Selected Use of Complementary and Alternative Medicine (CAM) Agents in IBD.Current gastroenterology reports · 2025Review
- Review
- Natural approaches for the management of ulcerative colitis: evidence of preclinical and clinical investigations.Natural products and bioprospecting · 2024Review
- Review
- 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
- A primer on common supplements and dietary measures used by patients with inflammatory bowel disease.Therapeutic advances in chronic disease · 2023Review
- Treatment-refractory ulcerative colitis responsive to indigo naturalis.BMJ open gastroenterology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIndigo naturalis (IN) is a blue pigment extracted from Assam indigo and other plants and has been confirmed to be highly effective for ulcerative colitis (UC) treatment in several clinical studies.
objectiveWe conducted a multicenter double-blind study to confirm the efficacy and safety of short-term IN administration.
methodsA multicenter, randomized controlled trial was conducted between December 2015 and October 2018 in our facilities. Forty-six patients with mild to moderate active UC (Lichtiger index: 5-10) were randomly assigned to the IN group or the placebo group and received 5 capsules (500 mg) twice a day for 2 weeks. We investigated the efficacy according to blood tests and the Lichtiger index before and after administration, and we also examined adverse events.
resultsThe analysis included 42 patients (20 males, 22 females) with an average age of 45 years. Nineteen patients were assigned to the placebo group, and 23 were assigned to the IN group. After treatment administration, in the placebo group, no change in the Lichtiger index was observed (7.47 to 6.95, p = 0.359), and hemoglobin was significantly reduced (12.7 to 12.4, p = 0.031), while in the IN group, the Lichtiger index (9.04 to 4.48, p = 0.001) and albumin (4.0 to 4.12, p = 0.022) improved significantly. Mild headaches were observed in 5 patients and 1 patient in the IN and placebo groups, respectively.
conclusionsShort-term administration of IN is highly effective without serious adverse events such as pulmonary hypertension or intussusception and may prevent the occurrence of serious adverse events.
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Registered trials
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.