Chinese herbal extract granules combined with 5-aminosalicylic acid for patients with moderately active ulcerative colitis: study protocol for a multicenter randomized double-blind placebo-controlled trial

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) remission. Given side effects burden, difficult most to achieve ideal treatment goals in clinical practice. Chinese herbal medicine (CHM), as complementary therapy, been widely used management UC China. Qing-Chang-Hua-Shi granule (QCHS) classical formula. Our preliminary study suggested that QCHS decoction significant effect on UC. However, its effectiveness safety not evaluated convincingly. Therefore, we designed this protocol investigate efficacy Methods This multicenter, randomized, double-blind, placebo-controlled, superiority trial. A total 120 will be recruited from 10 hospitals Each eligible participant randomly assigned receive or placebo 12 weeks. Both groups given basic mesalazine (4 g/day). The primary outcomes response (remission) rate. secondary health-related quality life, endoscopic rate, mucosal healing markers fecal calprotectin CRP). whole period last 36 weeks, including 24 weeks follow-up time. According intention-to-treat principle, variables assessed at 2, 4, 6, 8, 10, after commencement. Discussion first randomized controlled regarding extract granules We aim over terms If trial shows benefits granules, help practitioners, patients, policymakers make more informed choices decision-making. Trial registration Clinical Registry ChiCTR-IOR-14005554 . Registered 27 November 2014.