title: Induction with NCB-02 (curcumin) enema for mild-to-moderate distal ulcerative colitis - a randomized, placebo-controlled, pilot study.
abstract: OBJECTIVE
  Curcumin, an active ingredient of turmeric with anti-inflammatory properties, has been demonstrated to be useful in experimental models of ulcerative colitis (UC). It's efficacy in humans needs to be investigated.
  
  
  METHODS
  A randomized, double-blind, single-centre pilot trial was conducted in patients with distal UC (<25 cm involvement) and mild-to-moderate disease activity. Forty-five patients were randomized to either NCB-02 (standardized curcumin preparation) enema plus oral 5-ASA or placebo enema plus oral 5-ASA. Primary end point was disease response, defined as reduction in Ulcerative Colitis Diseases Activity Index by 3 points at 8 weeks, and secondary end points were improvement in endoscopic activity and disease remission at 8 weeks.
  
  
  RESULTS
  Response to treatment was observed in 56.5% in NCB-02 group compared to 36.4% (p=0.175) in placebo group. At week 8, clinical remission was observed in 43.4% of patients in NCB-02 group compared to 22.7% in placebo group (p=0.14) and improvement on endoscopy in 52.2% of patients in NCB-02 group compared to 36.4% of patients in placebo group (p=0.29). Per protocol analysis revealed significantly better outcomes in NCB-02 group, in terms of clinical response (92.9% vs. 50%, p=0.01), clinical remission (71.4% vs. 31.3%, p=0.03), and improvement on endoscopy (85.7% vs. 50%, p=0.04).
  
  
  CONCLUSIONS
  In this pilot study we found some evidence that use of NCB-02 enema may tend to result in greater improvements in disease activity compared to placebo in patients with mild-to-moderate distal UC. The role of NCB-02 as a novel therapy for UC should be investigated further.
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: vikaspisces@yahoo.co.in.
authors.forename: Vikas
authors.initials: V
authors.lastname: Singla
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: pratapmouli@yahoo.com.
authors.forename: Venigalla
authors.initials: V
authors.lastname: Pratap Mouli
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: sushilaiims@gmail.com.
authors.forename: Sushil Kumar
authors.initials: SK
authors.lastname: Garg
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: rai.tarun@gmail.com.
authors.forename: Tarun
authors.initials: T
authors.lastname: Rai
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: drbikashchoudhury@yahoo.com.
authors.forename: Bikash Narayan
authors.initials: BN
authors.lastname: Choudhury
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: prashverma78@gmail.com.
authors.forename: Prashant
authors.initials: P
authors.lastname: Verma
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: rachana.deb@gmail.com.
authors.forename: Rachana
authors.initials: R
authors.lastname: Deb
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: veena_mishra1@yahoo.com.
authors.forename: Veena
authors.initials: V
authors.lastname: Tiwari
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: rohatgisarika@yahoo.com.
authors.forename: Sarika
authors.initials: S
authors.lastname: Rohatgi
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: drrajandhingra@gmail.com.
authors.forename: Rajan
authors.initials: R
authors.lastname: Dhingra
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: dr.saurabhkedia@yahoo.com.
authors.forename: Saurabh
authors.initials: S
authors.lastname: Kedia
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: piyush020691@gmail.com.
authors.forename: Piyush Kumar
authors.initials: PK
authors.lastname: Sharma
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: govindmakharia@gmail.com.
authors.forename: Govind
authors.initials: G
authors.lastname: Makharia
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: vins_ahuja@hotmail.com.
authors.forename: Vineet
authors.initials: V
authors.lastname: Ahuja
mesh_terms: D000285:Administration, Rectal; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D003474:Curcumin / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D016099:Endoscopy, Gastrointestinal; D004733:Enema; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use; D008875:Middle Aged; D010865:Pilot Projects; D012074:Remission Induction / Q000379:methods; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine; D003474:Curcumin
keywords: Curcumin; NCB-02; Ulcerative colitis