Scientific evidence of Qing Dai​

Scientific evidence in the supplementation of ulcerative colitis

Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study. Shinya Sugimoto et al. Digestion. 2016

Clinical efficacy and safety of oral Qing-Dai (QD) in patients with UC: Open-label, prospective, single-center study.

Researchers from Keio University Hospital analyzed the efficacy of orally administered QD to induce remission in patients with ulcerative colitis.

20 patients with mild to moderate activity UC received oral Indigo naturalis, in capsule form twice daily (daily dose: 2 g), for 8 weeks.

At week 8, 72% of patients showed clinical response, 33% achieved clinical remission, and 61% achieved mucosal healing. Clinical and endoscopic indices, CRP levels, and fecal occult blood test results showed significant improvement.

The study concluded that QD is effective in inducing remission in patients with moderate UC.

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Efficacy of Indigo Naturalis in a Multicenter Randomized Controlled Trial of Patients With Ulcerative Colitis. Makoto Naganuma et al. Gastroenterology. 2018

Efficacy of Indigo naturalis (QD) in a multicenter randomized clinical trial compared to placebo in patients with UC.

In 2016, Japanese researchers conducted a estudio multicéntrico, doble ciego, aleatorizado y controlado con placebo en pacientes con CU activa que presentaban un índice de actividad >= 6 según el índice Mayo.

86 patients were included and randomly assigned to the different groups, receiving a daily dose of 0.5, 1.0, or 2.0 g of QD or placebo for 8 weeks.

 

Clinical response rates achieved were 69.6%, 75%, and 81% in the groups receiving QD at doses of 0.5 g, 1 g, and 2 g, respectively.

After 8 weeks, patients in the QD groups showed significantly higher remission rates than the placebo group.

60% of the group receiving 1.0 g showed mucosal healing, and the other 2 QD groups had slightly lower percentages.

The researchers concluded that 8-week of QD supplementation is effective in inducing clinical remission in patients with UC.

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Efficacy and safety of short-term therapy with indigo naturalis for ulcerative colitis: An investigator-initiated multicenter double-blind clinical trial. Uchiyama Kan et al, PLoS ONE. 2020

Efficacy and safety of short-term supplementation with indigo naturalis (QD) for ulcerative colitis: multicenter double-blind investigator-initiated. clinical trial.

The aim of this trial was to determine the safety and efficacy of Qing Dai (QD) in patients with mild to moderate ulcerative colitis.

46 patients (mean age 45 years) were split between the placebo and QD groups and were given 5 capsules (500 mg) twice daily for 2 weeks. Blood tests and disease activity measurement according to the Lichtiger index were performed before and after supplementation.

The placebo group did not experience any change in the Lichtiger index, while the QD group showed significant improvement in the Lichtiger index and albumin levels. No serious adverse events occurred. 

The researchers concluded that short-term QD administration is a very effective and safe adjunct.

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Efficacy of Indigo Naturalis (QD) Therapy for Ulcerative Colitis: A Case Series. Urushikubo Jun et al. Intern Med. 2019

This retrospective, observational study evaluated 14 patients with UC receiving QD supplementation.

After 8 weeks of oral treatment, the mean abbreviated Mayo score decreased from 4 (2-5) to 1.5 (0-4). 

50% of patients showed clinical response and 40% achieved clinical remission.

The study concluded that QD is an effective adjunct in helping induce remission in patients with UC.

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Qing-Dai for pediatric ulcerative colitis multicenter survey and systematic review. Kudo Takahiro et al. Pediatr Int. 2022

Systematic review and multicenter survey on the use of Qing-Dai for pediatric ulcerative colitis.

This clinical trial reviewed the efficacy of QD supplementation in 107 pediatric patients with UC.

At 6 months, 80.2% of patients had achieved clinical remission.

The researchers concluded that QD was “highly effective” for treating UC in children.

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Indigo Naturalis (QD) is effective even in treatment-refractory patients with ulcerative colitis: a post hoc analysis from the INDIGO study. Naganuma Makoto et al. J Gastroenterol. 2020.

Indigo naturalis (QD) is effective for the complementary management of steroid-dependent ulcerative colitis. 

In this post-hoc analysis, researchers analyzed data from a previous double-blind, multicenter clinical trial that evaluated the efficacy and safety of QD in inducing a clinical response in patients with active UC.

Patients received placebo or QD randomly for 8 weeks.

Researchers measured clinical response and mucosal healing rate in refractory versus non-refractory patients.

The clinical response rate was 77.8% in steroid-dependent patients, 77.5% in patients who had previously received anti-TNF-α, 70.8% in patients with concomitant thiopurine treatment, and 76.7% in patients with an endoscopic Mayo score of 9-11. No patient in the placebo group achieved clinical response.

The QD group showed a significantly higher mucosal healing rate than the placebo group in steroid-dependent patients.

Furthermore, the QD group showed a decrease in fecal calprotectin levels at 8 weeks in steroid-dependent UC patients.

Researchers determined that 8-week supplementation with QD is effective in inducing clinical response and mucosal healing, even in patients with steroid-dependent UC or those unresponsive to anti-TNF-α drugs.

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Treatment with indigo naturalis for inflammatory bowel disease and other immune diseases. Makoto Naganuma et al. Immunological Medicine. 2019

This open-label, prospective, single-center study evaluated the efficacy and safety of QD for treating active UC. 2g of QD were administered to 20 patients with mild to moderate UC for 8 weeks.

At week 8, 72% of patients showed clinical response, 33% achieved clinical remission, and 61% achieved mucosal healing.

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Scientific evidence of Qing Dai in the treatment of Crohn’s Disease (CD)

Short-term and long-term outcomes of indigo naturalis treatment for inflammatory bowel disease. Yuichi Matsuno et al. J Gastroenterol Hepatol. 2020

This questionnaire analyzed data collected from medical records of patients with inflammatory bowel disease (IBD) who started QD supplementation at Kyushu University Hospital. Remission and clinical response rates were calculated based on the clinical activity index determined by the Rachmilewitz index (CAI) or the Crohn’s disease activity index (CDAI).

The study included 17 patients with ulcerative colitis and 8 patients with Crohn’s disease.

At 8 weeks, UC patients showed clinical response rates of 94.1%, and 88.2% achieved remission. 

Among CD patients, the clinical response was 37.5% and remission rates were 25%.

Researchers concluded that QD shows a “favorable” therapeutic efficacy in UC patients and a “moderate” efficacy in CD patients.

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