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Original Article

IBD

One-year clinical efficacy and safety of indigo naturalis for active ulcerative colitis: a real-world prospective study: Yuichi Matsuno, Takehiro Torisu, Junji Umeno, Hiroki Shibata, Atsushi Hirano, Yuta Fuyuno, Yasuharu Okamoto, Shin Fujioka, Keisuke Kawasaki, Tomohiko Moriyama, Tomohiro Nagasue, Keizo Zeze, Yoichiro Hirakawa, Shinichiro Kawatoko, Yutaka Koga, Yoshinao Oda, Motohiro Esaki, Takanari Kitazono; Intest Res 2022;20(2):260-268. Published online April 29, 2022; DOI: https://doi.org/10.5217/ir.2021.00124

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Recent studies suggested a favorable effect of indigo naturalis (IN) in inducing remission for refractory ulcerative colitis (UC), however, the maintenance effect of IN for patients with UC remains unknown. Therefore, we conducted a prospective uncontrolled open-label study to analyze the efficacy and safety of IN for patients with UC.
Methods
Patients with moderate to severe active UC (clinical activity index [CAI] ≥ 8) took 2 g/day of IN for 52 weeks. CAI at weeks 0, 4, 8, and 52 and Mayo endoscopic subscore (MES) and Geboes score (GS) at weeks 0, 4, and 52 were assessed. Clinical remission (CAI ≤ 4), mucosal healing (MES ≤ 1), and histological healing (GS ≤ 1) rates at each assessment were evaluated. Overall adverse events (AEs) during study period were also evaluated. The impact of IN on mucosal microbial composition was assessed using 16S ribosomal RNA gene sequences.
Results
Thirty-three patients were enrolled. The rates of clinical remission at weeks 4, 8, and 52 were 67%, 76%, and 73%, respectively. The rates of mucosal healing at weeks 4 and 52 were 48% and 70%, respectively. AEs occurred in 17 patients (51.5%) during follow-up. Four patients (12.1%) showed severe AEs, among whom 3 manifested acute colitis. No significant alteration in the mucosal microbial composition was observed with IN treatment.
Conclusions
One-year treatment of moderate to severe UC with IN was effective. IN might be a promising therapeutic option for maintaining remission in UC, although the relatively high rate of AEs should be considered.

Citations

Citations to this article as recorded by

Risk of Infection in Patients With Inflammatory Bowel Disease Treated With Interleukin-Targeting Agents: A Systematic Review and Meta-Analysis
Konstantinos Ouranos, Hira Saleem, Stephanos Vassilopoulos, Athanasios Vassilopoulos, Evangelia K Mylona, Fadi Shehadeh, Markos Kalligeros, Bincy P Abraham, Eleftherios Mylonakis
Inflammatory Bowel Diseases.2025; 31(1): 37. CrossRef
Selected Use of Complementary and Alternative Medicine (CAM) Agents in IBD
Monica Dzwonkowski, Janak Bahirwani, Samantha Rollins, Alicia Muratore, Vikram Christian, Yecheskel Schneider
Current Gastroenterology Reports.2025;[Epub] CrossRef
Indigo naturalis‑associated ischemic injury of colorectal mucosa: A case series study
Yiheng Ke, Liang Xu, Qi Tang, Zheyu Ruan, Junjie Liu, Shuiliang Ruan
Experimental and Therapeutic Medicine.2025;[Epub] CrossRef
Safety and Effectiveness of QingDai (Indigo naturalis) in Children With Mild-to-Moderate Ulcerative Colitis: A Short-Term 6-Week Open-Label Trial
Dotan Yogev, Yael Weintraub, Oren Ledder, Manar Matar, Alex Krauthammer, Zivia Shavit-Brunschwig, Amichay Rotstein, Max E Godfrey, Amit Assa, Raanan Shamir, Dan Turner, Nir Salomon, Esther Orlanski-Meyer, Dror S Shouval
Inflammatory Bowel Diseases.2025; 31(10): 2917. CrossRef
Macrophage‐Mediated Transport of Insoluble Indirubin Induces Hepatic Injury During Intestinal Inflammation
Yiqi Xu, Jingchun Shi, Heung‐Lam Mok, Cheng Lyu, Junbang Chen, Chunhua Huang, Hongyan Qin, Chengyuan Lin, Hor‐Yue Tan, Zhaoxiang Bian
Advanced Science.2025;[Epub] CrossRef
Indigo naturalis for inflammatory bowel disease: evidence from animal studies and molecular mechanisms
Jie Hu, Mengen Zhou, Li Huang, Xiutian Guo, Pingping Mei, Peng Li, Yiting Wang, Yan Chen
Frontiers in Pharmacology.2025;[Epub] CrossRef
Reaching for Remission: Integrating Complementary and Alternative Strategies into Inflammatory Bowel Disease Management
Kelsey Ryan, Asha Cunningham, Joseph Runde
Pediatric Annals.2025;[Epub] CrossRef
Understanding Vascular Toxicity of Indigo Naturalis in Anti-Inflammatory Applications: Mendelian Randomization and Co-localization Study
Jie Liu, Chengjian Liu, Haitao Xiao, Zhiping Xu
BIO Integration.2025;[Epub] CrossRef
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Rinkalben Kakdiya, Daya Krishna Jha, Arup Choudhury, Anuraag Jena, Vishal Sharma
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Reply to “Ferroptosis in the colon epithelial cells as a therapeutic target for ulcerative colitis”
Akihito Yokote, Noriyuki Imazu, Junji Umeno, Keisuke Kawasaki, Shin Fujioka, Yuta Fuyuno, Yuichi Matsuno, Tomohiko Moriyama, Kohta Miyawaki, Koichi Akashi, Takanari Kitazono, Takehiro Torisu
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Clinical Efficacy and Future Application of Indigo Naturalis in the Treatment of Ulcerative colitis
Dianzhen Wu, Qi Huang, Yingbi Xu, Ruiyi Cao, Ming Yang, Jin Xie, Dingkun Zhang
Journal of Ethnopharmacology.2024; : 118782. CrossRef
Ferroptosis in the colon epithelial cells as a therapeutic target for ulcerative colitis
Akihito Yokote, Noriyuki Imazu, Junji Umeno, Keisuke Kawasaki, Shin Fujioka, Yuta Fuyuno, Yuichi Matsuno, Tomohiko Moriyama, Kohta Miyawaki, Koichi Akashi, Takanari Kitazono, Takehiro Torisu
Journal of Gastroenterology.2023; 58(9): 868. CrossRef
Hyaluronic acid/inulin-based nanocrystals with an optimized ratio of indigo and indirubin for combined ulcerative colitis therapy via immune and intestinal flora regulation
Jin Xie, Qi Huang, Huijuan Xie, Jun Liu, Shimin Tian, Ruiyi Cao, Ming Yang, Junzhi Lin, Li Han, Dingkun Zhang
International Journal of Biological Macromolecules.2023; 252: 126502. CrossRef
High-Quality Indigo Naturalis Obtained with Automatic Foam Separation
Xin Yang, Jun Tang, Juan Su, Xin Yang, Ming Yang, Xiangbo Yang, Qisen Ji, Yanan He, Li Han, Dingkun Zhang
ACS Applied Materials & Interfaces.2023; 15(37): 43272. CrossRef

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Review

IBD

Current new challenges in the management of ulcerative colitis: Tomohiro Fukuda, Makoto Naganuma, Takanori Kanai; Intest Res 2019;17(1):36-44. Published online January 25, 2019; DOI: https://doi.org/10.5217/ir.2018.00126

Abstract PDF PubReader ePub

Ulcerative colitis (UC) is a chronic inflammatory condition of the gastrointestinal tract. Although the cause of UC is postulated to be multifactorial in nature, including genetic predisposition, epithelial barrier defects, dysregulation of immune responses, and environmental factors, the specific pathogenesis of UC is still incompletely understood. In the treatment of UC so far, a method of suppressing immunity and treating it has been mainstream. Immunosuppressant drugs, including thiopurines (azathioprine or 6-mercaptopurine), anti-tumor necrosis factor-α (anti-TNF-α) antibody (infliximab and adalimumab), and calcineurin inhibitor, can be used in treat patients with corticosteroid-dependent and/or corticosteroid-refractory moderateto- severe UC. Recently, in addition to such a conventional therapeutic agent, golimumab, which is the first transgenic human monoclonal anti-TNF-α antibody to be fabricated, anti α-4/β-7 integrin antibody, and Janus kinase inhibitor have been reported to novel immunosuppressant therapy. Furthermore, other treatments with unique mechanisms different from immunosuppression, have also been suggested, including fecal microbiota transplantation and Indigo naturalis, which is a Chinese herbal medicine. We compared the features and efficacy of these new treatments. In this issue, the features and treatment options for these new treatments is reviewed.

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