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) 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 for 12 weeks. Both groups will be given basic treatment with mesalazine (4 g/day). 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 randomized controlled clinical study protocol 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. If the trial shows significant benefits of QCHS granules, it will 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.

Efficacy and safety of Chinese patent medicine combined with 5-aminosalicylic acid for patients with ulcerative colitis: A network meta-analysis of randomized controlled trials

“…Chinese patent medicines (CPMs) are commercial traditional Chinese medicine (TCM) preparations made with the approval of China's drug regulatory department under the guidance of TCM theory. Several clinical Randomized controlled trials (RCTs) have demonstrated that the combination of CPMs with 5-ASA could maintain long-term remission and reduce the recurrence rate [ 8 , 9 ]. However, the wide range of CPMs available for UC treatment poses a challenge for clinicians in selecting the most suitable option, particularly for patients with varying disease presentations.…”

Development of Multi-particulate Formulation of Glabridin with L-Phenylalanine and Its Pre-clinical Evaluation for Anti-obesity Activity

“…[12][13][14] Even though many herbal drugs are effective, they lack off suitable dosage forms and result in problems with ease and accuracy of dosing of herbal drugs is one of the major factors that affect the overall acceptance of herbal drugs by patients as well as clinicians. [15][16][17] Formulating herbal active ingredients in dosage form, like granules, which are multi-particulate systems, can solve the problem of effectiveness and acceptance. And also solve the problem of dosing and palatability.…”