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Table 2 Clinical experiment of indigo naturalis in treating UC

From: From natural dye to herbal medicine: a systematic review of chemical constituents, pharmacological effects and clinical applications of indigo naturalis

Drugs

Clinic types of experiments

Number of examinees

Usage time

Results

Adverse reactions

Refs.

Indigo naturalis

Retrospective observational study

n = 14

8 weeks

In 10 active UC patients 50% had clinical response and 40% achieved clinical remission. Rachmilewitz endoscopic index (REI), and UC endoscopy index of severity (UCEIS). the Mayo endoscopic subscore (MES) decreased from 2 (2–3) to 1 (1–2), the Rachmilewitz endoscopic index (REI) decreased from 7 (5.5–11) to 3 (1–7), and the UC endoscopy index (UCEIS) of severity decreased from 3 (3-4.5) to 1 (0.5–3.5)

One patient developed right colitis with intestinal wall thickening and edema

[88]

Indigo naturalis oil suppository

Open-label, single-center, prospective pilot study

n = 10

4 weeks

30% of patients achieved clinical remission, 40% of patients had mucosal healing. Mucosal healing was observed in 80% of patients with MES in the Rectum (R-MES) score of 2, but not in patients with scores of 3

One patient developed perianal pain

[89]

Indigo naturalis

A multicenter, double-blind trial

n = 86

8 weeks

The clinical response of UC was correlated with the oral dose of indigo naturalis. 13.6% of patients had clinical response to placebo; 69.6% to 0.5 g indigo naturalis; 75.0% to 1.0 g indigo naturalis and 81.0% to 2.0 g indigo naturalis. At week 8, 56.6% patients with 0.5 g, 60% with 1.0 g and 47.6% with 2.0 g indigo naturalis received clinical relief compared to 13.6% placebo

Mild liver dysfunction was observed in 10 patients taking indigo naturalis, but there were no significant adverse reactions. Unfortunately, the experiment was terminated because a patient took indigo naturalis by heself and developed pulmonary hypertension

[90]

Indigo naturalis

Retrospective observational study

n = 17 in UC

and n = 8 in Crohn’s disease (CD)

8 weeks

There are 94.1% and 88.2% in UC and 37.5% and 25.0% in CD receiving Clinical response and clinical remission, respectively

During follow-up, 10 patients developed adverse reactions, and 3 patients experienced severe adverse reactions, including 2 cases of acute colitis requiring hospitalization and 1 case of acute colitis intussusception requiring surgical treatment

[91]

52 weeks

And 104 weeks

Through non-responders imputation analyses at weeks 52 and 104, the clinical remission rates were 76.4% and 70.4% in UC patients and 25.0% and 25.0% in CD patients