Induction with NCB-02 (curcumin) enema for mild-to-moderate distal ulcerative
colitis - a randomized, placebo-controlled, pilot study.
Author(s): Singla V(1), Pratap Mouli V(2), Garg SK(3), Rai T(4), Choudhury BN(5), Verma
P(6), Deb R(7), Tiwari V(8), Rohatgi S(9), Dhingra R(10), Kedia S(11), Sharma
PK(12), Makharia G(13), Ahuja V(14).
Affiliation(s): Author information:
(1)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: vikaspisces@yahoo.co.in.
(2)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: pratapmouli@yahoo.com.
(3)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: sushilaiims@gmail.com.
(4)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: rai.tarun@gmail.com.
(5)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address:
drbikashchoudhury@yahoo.com.
(6)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: prashverma78@gmail.com.
(7)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: rachana.deb@gmail.com.
(8)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: veena_mishra1@yahoo.com.
(9)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: rohatgisarika@yahoo.com.
(10)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: drrajandhingra@gmail.com.
(11)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address:
dr.saurabhkedia@yahoo.com.
(12)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: piyush020691@gmail.com.
(13)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: govindmakharia@gmail.com.
(14)Department of Gastroenterology and Human Nutrition, All India Institute of
Medical Sciences, New Delhi, India. Electronic address: vins_ahuja@hotmail.com.
Publication date & source: 2014, J Crohns Colitis. , 8(3):208-14
BACKGROUND AND AIMS: 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).
CONCLUSION: 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.
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