Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis - a double-blind comparison with sustained release mesalazine

Aliment Pharmacol Ther. 2011 Jan;33(2):194-202. doi: 10.1111/j.1365-2036.2010.04515.x. Epub 2010 Nov 30.


Background: Andrographis paniculata is an herbal mixture used to treat inflammatory diseases. An extract of the herb, HMPL-004, inhibits TNF-α and IL-1β, and prevents colitis in animal models.

Aim: To determine the efficacy and safety of HMPL-004 in patients with mild-to-moderate ulcerative colitis.

Methods: A randomised, double-blind, multicentre, 8-week parallel group study was conducted using HMPL-004 1200 mg/day compared with 4500 mg/day of slow release mesalazine (mesalamine) granules in patients with mild-to-moderately active ulcerative colitis. Disease activity was assessed at baseline and every 2 weeks for clinical response, and at baseline and 8 weeks by colonoscopy.

Results: One hundred and twenty patients at five centres in China were randomised and dosed. Clinical remission and response were seen in 21% and 76% of HMPL-004-treated patients, and 16% and 82% of mesalazine-treated patients. By colonoscopy, remission and response were seen in 28% and 74% of HMPL-004-treated patients and 24% and 71% of mesalazine-treated patients, respectively. There was no significant difference between the two treatment groups.

Conclusion: HMPL-004 may be an efficacious alternative to mesalazine in ulcerative colitis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acanthaceae / chemistry
  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • China
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / physiopathology
  • Dietary Supplements
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Mesalamine / therapeutic use*
  • Middle Aged
  • Plant Preparations / therapeutic use*
  • Severity of Illness Index
  • Treatment Outcome
  • Young Adult


  • Anti-Inflammatory Agents, Non-Steroidal
  • Plant Preparations
  • Mesalamine