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
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
Indigo naturalis (Qing dai) for inflammatory bowel disease: A systematic review and meta-analysis Rinkalben Kakdiya, Daya Krishna Jha, Arup Choudhury, Anuraag Jena, Vishal Sharma Clinics and Research in Hepatology and Gastroenterology.2024; 48(1): 102250. CrossRef
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 Journal of Gastroenterology.2024; 59(1): 77. CrossRef
Herbal Medicines for the Treatment of Active Ulcerative Colitis: A Systematic Review and Meta-Analysis Preetha Iyengar, Gala Godoy-Brewer, Isha Maniyar, Jacob White, Laura Maas, Alyssa M. Parian, Berkeley Limketkai Nutrients.2024; 16(7): 934. CrossRef
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
Background/Aims Gastrointestinal stromal tumor (GIST) is one of the most common types of submucosal tumors (SMTs). Because of GIST’s malignant potential, it is crucial to differentiate it from other SMTs. The present study aimed to identify characteristic endoscopic findings of GISTs in the small intestine.
Methods We reviewed the clinicopathological and endoscopic findings of 38 patients with endoscopically or surgically resected SMTs in the small intestine. SMTs were classified into GIST and non-GIST groups, and clinicopathological and endoscopic findings were compared between the 2 groups.
Results Fifteen patients had GIST and 23 patients had other types of SMTs in the small intestine. Comparison of the endoscopic findings between the 2 groups revealed that dilated vessels in the surrounding mucosa were significantly more in number in the GIST group than in the non-GIST group (P<0.05). However, there were no other differences in endoscopic findings between the 2 groups. Among patients with GISTs, the presence of dilated vessels in the surrounding mucosa was not associated with bleeding risk, tumor size, or metastasis rate at diagnosis.
Conclusions Dilated vessels in the surrounding mucosa, identified during balloon-assisted endoscopy, may be a diagnostic indicator for GIST in the small intestine. However, its clinical significance should be further analyzed.
Citations
Citations to this article as recorded by
Rapidly Growing Gastrointestinal Stromal Tumor on the Esophagus Ji Hye Park, Sung Eun Kim, Seun Ja Park, Moo In Park, Won Moon, Jae Hyun Kim, Kyoungwon Jung, Myung Hun Lee The Korean Journal of Helicobacter and Upper Gastrointestinal Research.2025; 25(1): 64. CrossRef
Multiple Small Bowel Gastrointestinal Stromal Tumors Associated with Neurofibromatosis Type 1 that Were Not Detected by Endoscopy: A Case Report Satomi Saito, Teppei Omori, Shun Murasugi, Maria Yonezawa, Yukiko Takayama, Takeshi Ohki, Hiromi Onizuka, Yoji Nagashima, Katsutoshi Tokushige Case Reports in Gastroenterology.2023; 17(1): 167. CrossRef
Convolutional neural network‐based object detection model to identify gastrointestinal stromal tumors in endoscopic ultrasound images Chang Kyo Oh, Taewan Kim, Yu Kyung Cho, Dae Young Cheung, Bo‐In Lee, Young‐Seok Cho, Jin Il Kim, Myung‐Gyu Choi, Han Hee Lee, Seungchul Lee Journal of Gastroenterology and Hepatology.2021; 36(12): 3387. CrossRef
Small Bowel Malignancies in Patients Undergoing Capsule Endoscopy for Iron Deficiency Anemia Su Hwan Kim, Ji Won Kim Diagnostics.2021; 12(1): 91. CrossRef