title: Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study.
abstract: OBJECTIVE
  Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients.
  
  
  METHODS
  The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks.
  
  
  RESULTS
  At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea.
  
  
  CONCLUSIONS
  This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Sugimoto
authors.forename: Makoto
authors.initials: M
authors.lastname: Naganuma
authors.forename: Hiroki
authors.initials: H
authors.lastname: Kiyohara
authors.forename: Mari
authors.initials: M
authors.lastname: Arai
authors.forename: Keiko
authors.initials: K
authors.lastname: Ono
authors.forename: Kiyoto
authors.initials: K
authors.lastname: Mori
authors.forename: Keiichiro
authors.initials: K
authors.lastname: Saigusa
authors.forename: Kosaku
authors.initials: K
authors.lastname: Nanki
authors.forename: Kozue
authors.initials: K
authors.lastname: Takeshita
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Takeshita
authors.forename: Makoto
authors.initials: M
authors.lastname: Mutaguchi
authors.forename: Shinta
authors.initials: S
authors.lastname: Mizuno
authors.forename: Rieko
authors.initials: R
authors.lastname: Bessho
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Nakazato
authors.forename: Tadakazu
authors.initials: T
authors.lastname: Hisamatsu
authors.forename: Nagamu
authors.initials: N
authors.lastname: Inoue
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Ogata
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Iwao
authors.forename: Takanori
authors.initials: T
authors.lastname: Kanai
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002214:Capsules; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy*; D003113:Colonoscopy; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects*; D007564:Japan; D008297:Male; D008516:Medicine, Chinese Traditional / Q000379:methods*; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012074:Remission Induction / Q000379:methods; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002214:Capsules; D004365:Drugs, Chinese Herbal; C530990:Qingdai compound