Andrographis paniculata extract (HMPL-004) for active ulcerative colitis.

Area of Science:

• Phytotherapy
• Gastroenterology
• Immunology

Background:

• Andrographis paniculata exhibits in vitro inhibitory effects on TNF-α, IL-1β, and NF-κB.
• A prior pilot study indicated that A. paniculata extract (HMPL-004) may be as effective as mesalamine for ulcerative colitis management.

Purpose of the Study:

• To evaluate the efficacy of A. paniculata extract (HMPL-004) in adults diagnosed with mild-to-moderate ulcerative colitis.
• To compare the effects of two different daily dosages of A. paniculata extract against a placebo.

Main Methods:

• A randomized, double-blind, placebo-controlled trial involving 224 adult participants.
• Patients received either 1,200 mg or 1,800 mg of A. paniculata extract (HMPL-004) daily, or a placebo, for a duration of 8 weeks.

Main Results:

• A clinical response was observed in 60% of patients receiving 1,800 mg of A. paniculata daily, which was significantly higher than the 40% in the placebo group (P=0.0183).
• Clinical remission rates were 38% for the 1,800 mg group versus 25% for placebo (P=0.1011).
• Adverse event incidence was comparable across the groups: 60% (1,200 mg), 53% (1,800 mg), and 60% (placebo).

Conclusions:

• The 1,800 mg daily dose of Andrographis paniculata extract (HMPL-004) demonstrated a higher likelihood of achieving clinical response in patients with mild-to-moderate ulcerative colitis compared to placebo.
• Further research may be warranted to explore the therapeutic potential of this herbal extract in managing ulcerative colitis.