Research

Indirubin

19 peer-reviewed studies curated from PubMed and Semantic Scholar.

1
Meta-analyses
0
Systematic reviews
14
RCTs
4
Other studies
Meta-analyses (5%)
RCTs (74%)

Studies

Sorted by quality and recency

2023·Clinics and research in hepatology and gastroenterology·Rinkalben Kakdiya, Daya Krishna Jha, Arup Choudhury, et al

Indigo naturalis (Qing dai) for inflammatory bowel disease: A systematic review and meta-analysis.

Meta-analysisn = 299Gut Health

Systematic review and meta-analysis of indigo naturalis (Qing dai) for inflammatory bowel disease, focusing on ulcerative colitis. The pooled clinical response rate was 79.6%, and the clinical remission rate in ulcerative colitis was 66.8%. Indigo naturalis showed higher clinical response compared to placebo in randomized trials, with mostly mild adverse effects.

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2025·Biochemical pharmacology·Jeffry S Tang, Alissa Cait, David O'Sullivan, et al

Pharmacokinetics of major indigo naturalis indole alkaloids in humans and their association with systemic aryl hydrocarbon receptor activity.

RCT

Open-label, placebo-controlled, dose-escalation study of orally-administered indigo naturalis in healthy individuals. The study measured pharmacokinetics and net AhR agonistic activity in blood, finding that AhR activity increased dose-dependently, initially through tryptanthrin and later sustained by indirubin.

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2021·BMJ open gastroenterology·Julie P Saiki, Johan Ol Andreasson, Kevin V Grimes, et al

Treatment-refractory ulcerative colitis responsive to indigo naturalis.

RCTn = 11Gut Health

Open-label, dose-escalation study of indigo naturalis (IN) in 11 patients with treatment-refractory ulcerative colitis. 91% of patients achieved a clinical response, with improvements in endoscopic severity and quality of life. The study suggests IN's efficacy is likely through AhR activation.

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2020·PloS one·Kan Uchiyama, Shinichiro Takami, Hideo Suzuki, et al

Efficacy and safety of short-term therapy with indigo naturalis for ulcerative colitis: An investigator-initiated multicenter double-blind clinical trial.

RCTn = 42Gut Health

A multicenter double-blind RCT evaluated the efficacy and safety of indigo naturalis (IN) in 42 patients with mild to moderate ulcerative colitis. The IN group showed significant improvement in the Lichtiger index and albumin levels compared to the placebo group, with mild headaches as the only noted adverse event.

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2019·Journal of gastroenterology·Makoto Naganuma, Shinya Sugimoto, Tomohiro Fukuda, et al

Indigo naturalis is effective even in treatment-refractory patients with ulcerative colitis: a post hoc analysis from the INDIGO study.

RCTn = 86Gut Health

Post hoc analysis of the INDIGO study, a randomized controlled trial, assessing the efficacy of indigo naturalis in 86 patients with active ulcerative colitis, including treatment-refractory cases. Indigo naturalis showed higher rates of clinical response and mucosal healing compared to placebo, even in patients with steroid-dependent disease and previous anti-TNF-α use.

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2017·Gastroenterology·Makoto Naganuma, Shinya Sugimoto, Keiichi Mitsuyama, et al

Efficacy of Indigo Naturalis in a Multicenter Randomized Controlled Trial of Patients With Ulcerative Colitis.

RCTn = 86Gut Health

A multicenter, double-blind RCT evaluated the efficacy and safety of indigo naturalis (IN) in 86 patients with active ulcerative colitis. The study found a significant, dose-dependent clinical response and remission in patients treated with IN compared to placebo. However, the trial was terminated due to a report of pulmonary arterial hypertension in a patient using IN.

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2017·The British journal of dermatology·Y-K Lin, L-C See, Y-H Huang, et al

Comparison of indirubin concentrations in indigo naturalis ointment for psoriasis treatment: a randomized, double-blind, dosage-controlled trial.

RCTSkin Hair Health

Randomized, double-blind trial comparing different concentrations of indirubin in Lindioil ointment for treating psoriasis. The 200 μg group showed the greatest reduction in PASI score and the highest proportion of patients achieving PASI 75 and PASI 90. No severe treatment-related adverse events were reported.

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2015·JAMA dermatology·Yin-Ku Lin, Ya-Ching Chang, Rosaline Chung-Yee Hui, et al

A Chinese Herb, Indigo Naturalis, Extracted in Oil (Lindioil) Used Topically to Treat Psoriatic Nails: A Randomized Clinical Trial.

RCTSkin Hair Health

Randomized clinical trial investigating the topical use of Indigo Naturalis extracted in oil (Lindioil) for treating psoriatic nails.

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2012·Archives of dermatology·Yin-Ku Lin, Lai-Chu See, Yu-Huei Huang, et al

Comparison of refined and crude indigo naturalis ointment in treating psoriasis: randomized, observer-blind, controlled, intrapatient trial.

RCTSkin Hair Health

The study compares the effectiveness of refined and crude indigo naturalis ointment in treating psoriasis through a randomized, observer-blind, controlled, intrapatient trial.

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2019·Journal of ethnopharmacology·Yin-Ku Lin, Shu-Han Chang, Chin-Yi Yang, et al

Efficacy and safety of indigo naturalis ointment in Treating Atopic Dermatitis: A randomized clinical trial.

RCTn = 48Skin Hair Health

Randomized double-blind clinical trial of indigo naturalis ointment in 48 participants with atopic dermatitis. The Lindioil group showed a significant mean percentage reduction in Eczema Area Severity Index compared to the vehicle group, with no significant adverse events reported.

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2019·Digestion·Yusuke Yoshimatsu, Makoto Naganuma, Shinya Sugimoto, et al

Development of an Indigo Naturalis Suppository for Topical Induction Therapy in Patients with Ulcerative Colitis.

RCTn = 10Gut Health

Open-label, single-center, prospective pilot study evaluating the safety and efficacy of indigo naturalis suppositories in 10 patients with active ulcerative colitis. After 4 weeks, clinical remission and mucosal healing rates were 30% and 40%, respectively, with significant improvement in Mayo rectal bleeding subscores. Efficacy was limited by disease severity.

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2017·BMC complementary and alternative medicine·Hui-Man Cheng, Yang-Chang Wu, Qingmin Wang, et al

Clinical efficacy and IL-17 targeting mechanism of Indigo naturalis as a topical agent in moderate psoriasis.

RCTn = 24Skin Hair Health Inflammation

A randomized, double-blind, placebo-controlled clinical study evaluated the efficacy of Indigo naturalis as a topical treatment for moderate plaque psoriasis in a Chinese cohort. Significant improvements in Psoriasis Area and Severity Index (PASI) scores were observed in the Indigo naturalis group compared to placebo, with a 75% improvement in 56.3% of treated patients. The study also identified down-regulation of the IL-17 pathway as a mechanism of action.

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2014·Phytomedicine : international journal of phytotherapy and phytopharmacology·Yin-Ku Lin, Lai-Chu See, Yu-Huei Huang, et al

Efficacy and safety of Indigo naturalis extract in oil (Lindioil) in treating nail psoriasis: a randomized, observer-blind, vehicle-controlled trial.

RCTn = 31Skin Hair Health

RCT evaluating the efficacy and safety of refined indigo naturalis extract in oil (Lindioil) for treating nail psoriasis. Lindioil showed superior reduction in Nail Psoriasis Severity Index scores compared to olive oil, with no adverse events reported over 24 weeks.

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2008·Archives of dermatology·Yin-Ku Lin, Chee-Jen Chang, Ya-Ching Chang, et al

Clinical assessment of patients with recalcitrant psoriasis in a randomized, observer-blind, vehicle-controlled trial using indigo naturalis.

RCTn = 42Skin Hair Health

RCT evaluating the efficacy and safety of indigo naturalis ointment in 42 patients with recalcitrant plaque-type psoriasis. Significant reductions in scaling, erythema, and induration scores and plaque area percentage were observed, with 74% of patients experiencing clearance or near clearance of psoriasis.

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2007·Dermatology (Basel, Switzerland)·Yin-Ku Lin, Wen-Rou Wong, Ya-Ching Chang, et al

The efficacy and safety of topically applied indigo naturalis ointment in patients with plaque-type psoriasis.

RCTn = 14Skin Hair Health

RCT evaluating the efficacy and safety of topically applied indigo naturalis ointment in 14 patients with plaque-type psoriasis. Significant reduction in clinical scores and improvement in skin histology were observed, suggesting indigo naturalis as a safe and effective therapy for psoriasis.

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2023·International journal of biological macromolecules·Lin Li, Chang Liu, Jing Fu, et al

CD44 targeted indirubin nanocrystal-loaded hyaluronic acid hydrogel for the treatment of psoriasis.

Animal study

The study investigates the use of hyaluronic acid-based nanocarrier gels to deliver indirubin for psoriasis treatment. Indirubin nanocrystals were incorporated into a hydrogel matrix to enhance cutaneous absorption and target CD44 in psoriatic skin. The indirubin NC/HA gels improved indirubin accumulation and anti-psoriatic effects in a mouse model and HaCaT cells.

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2019·Experimental hematology·Kai Shao, Tengkai Wang, Tiantian Li, et al

Indirubin regulates MPL and TNF expression in peripheral blood mononuclear cells from patients with primary immune thrombocytopenia.

Studyn = 39Inflammation Immunity

The study investigated the effects of indirubin on gene expression in peripheral blood mononuclear cells from 19 ITP patients and 20 healthy controls. Indirubin enhanced MPL expression and inhibited TNF expression in ITP patients, suggesting a role in thrombopoiesis and inflammation suppression.

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2016·Digestion·Shinya Sugimoto, Makoto Naganuma, Hiroki Kiyohara, et al

Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study.

Studyn = 20Gut Health Inflammation

Open-label prospective study at Keio University Hospital evaluating oral Qing-Dai in 20 patients with moderate ulcerative colitis. At week 8, clinical response, remission, and mucosal healing rates were 72%, 33%, and 61%, respectively, with significant improvements in clinical and endoscopic scores, CRP levels, and fecal occult blood results. Mild liver dysfunction was observed in 2 patients, with discontinuation due to infectious colitis and mild nausea in 2 others.

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2011·Dermatology (Basel, Switzerland)·Yin-Ku Lin, Lai-Chu See, Ya-Ching Chang, et al

Treatment of psoriatic nails with indigo naturalis oil extract: a non-controlled pilot study.

Studyn = 32Skin Hair Health

Non-controlled pilot study evaluating the efficacy of indigo naturalis oil extract in patients with nail psoriasis. Patients applied the extract twice daily for 24 weeks, resulting in a decrease in NAPSI scores, indicating improvement in nail psoriasis.

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