In:
PLOS ONE, Public Library of Science (PLoS), Vol. 15, No. 11 ( 2020-11-5), p. e0241337-
Abstract:
Indigo naturalis (IN) is a blue pigment extracted from Assam indigo and other plants and has been confirmed to be highly effective for ulcerative colitis (UC) treatment in several clinical studies. Objective We conducted a multicenter double-blind study to confirm the efficacy and safety of short-term IN administration. Methods A multicenter, randomized controlled trial was conducted between December 2015 and October 2018 in our facilities. Forty-six patients with mild to moderate active UC (Lichtiger index: 5–10) were randomly assigned to the IN group or the placebo group and received 5 capsules (500 mg) twice a day for 2 weeks. We investigated the efficacy according to blood tests and the Lichtiger index before and after administration, and we also examined adverse events. Results The analysis included 42 patients (20 males, 22 females) with an average age of 45 years. Nineteen patients were assigned to the placebo group, and 23 were assigned to the IN group. After treatment administration, in the placebo group, no change in the Lichtiger index was observed (7.47 to 6.95, p = 0.359), and hemoglobin was significantly reduced (12.7 to 12.4, p = 0.031), while in the IN group, the Lichtiger index (9.04 to 4.48, p = 0.001) and albumin (4.0 to 4.12, p = 0.022) improved significantly. Mild headaches were observed in 5 patients and 1 patient in the IN and placebo groups, respectively. Conclusions Short-term administration of IN is highly effective without serious adverse events such as pulmonary hypertension or intussusception and may prevent the occurrence of serious adverse events.
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0241337
DOI:
10.1371/journal.pone.0241337.g001
DOI:
10.1371/journal.pone.0241337.g002
DOI:
10.1371/journal.pone.0241337.g003
DOI:
10.1371/journal.pone.0241337.g004
DOI:
10.1371/journal.pone.0241337.g005
DOI:
10.1371/journal.pone.0241337.t001
DOI:
10.1371/journal.pone.0241337.t002
DOI:
10.1371/journal.pone.0241337.s001
DOI:
10.1371/journal.pone.0241337.s002
DOI:
10.1371/journal.pone.0241337.s003
DOI:
10.1371/journal.pone.0241337.s004
DOI:
10.1371/journal.pone.0241337.s005
DOI:
10.1371/journal.pone.0241337.r001
DOI:
10.1371/journal.pone.0241337.r002
DOI:
10.1371/journal.pone.0241337.r003
DOI:
10.1371/journal.pone.0241337.r004
DOI:
10.1371/journal.pone.0241337.r005
DOI:
10.1371/journal.pone.0241337.r006
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2020
detail.hit.zdb_id:
2267670-3
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