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 |