Abstract
Background
Ulcerative colitis (UC) is an intestinal inflammatory disease characterized by inflammation of the colonic mucosa. With unknown pathogenesis, it has become a chronic lifetime disorder worldwide. In patients with moderately active UC, several therapies (e.g. aminosalicylates, corticosteroids, immunosuppressants and biologics) are recommended for induction (or maintenance) of remission. Given the side effects and disease burden, it is difficult for most patients to achieve ideal treatment goals in clinical practice. Chinese herbal medicine (CHM), as a complementary therapy, has been widely used in the management of UC in China. Qing-Chang-Hua-Shi granule (QCHS) is a classical Chinese herbal formula. Our preliminary study suggested that the QCHS decoction has a significant effect on patients with moderately active UC. However, its effectiveness and safety has not been evaluated convincingly. Therefore, we designed this protocol to investigate the efficacy of QCHS granule for moderately active UC.
Methods
This is a multicenter, randomized, double-blind, placebo-controlled, superiority trial. A total of 120 patients with moderately active UC will be recruited from 10 hospitals in China. Each eligible participant will be randomly assigned to receive QCHS granule or placebo twice daily for 12 weeks. Both groups will be given basic treatment with mesalazine (4 g/d). The primary outcomes are the clinical response (remission) rate. The secondary outcomes are health-related quality of life, endoscopic response rate, mucosal healing rate and inflammatory markers (e.g. Fecal calprotectin and CRP). The whole study period will last 36 weeks, including 24 weeks follow-up time. According to the intention-to-treat principle, variables will be assessed at 2, 4, 6, 8, 10 and 12 weeks after study commencement.
Discussion
This is the first prospective, multicenter, randomized, double-blind, placebo-controlled, superiority trial regarding Chinese herbal extract granules in the management of moderately active UC. We aim to investigate the superiority of QCHS granules over placebo in terms of induction of remission. The findings will provide convincing evidence on the efficacy and safety of QCHS granules for moderately active UC, which may help clinical practitioners, UC patients and policymakers make more informed choices in the decision-making.
Trial registration:
Chinese Clinical Trial Registry, ChiCTR-IOR-14005554. Registered on 27 November 2014.
P588 A randomized double blind placebo controlled trial to assess the efficacy of a probiotic preparation as maintenance therapy in patients with ulcerative colitis
